This section highlights FDA-related milestones and regulatory updates for drugs developed by AbbVie (ABBV).
Over the past two years, AbbVie has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Risankizumab-rzaa, SKYRIZI, RINVOQ, TrenibotE, ELAHERE, ABBV-295, and VENCLEXTA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Risankizumab-rzaa (SKYRIZI) FDA Regulatory Events
Risankizumab-rzaa (SKYRIZI) is a drug developed by AbbVie for the following indication: Moderate to Severe Crohn's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Risankizumab-rzaa (SKYRIZI)
- Announced Date:
- May 5, 2026
- Indication:
- Moderate to Severe Crohn's Disease
Announcement
AbbVie announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI® (risankizumab-rzaa) and RINVOQ® (upadacitinib) in Crohn's disease and ulcerative colitis.
AI Summary
AbbVie announced it will present new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2–5 in Chicago. The company will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI (risankizumab-rzaa) and RINVOQ (upadacitinib) in Crohn’s disease and ulcerative colitis. The submissions include results from both clinical trials and everyday clinical practice.
Key highlights include real-world data showing a low switch rate to risankizumab among Crohn’s patients, lower odds of hospitalization after switching to upadacitinib, and endoscopic improvements in difficult-to-treat Crohn’s disease. AbbVie says this breadth of evidence supports the efficacy, safety profile, and durability of both medicines and will offer longer-term and practical insights to clinicians treating Crohn’s disease and ulcerative colitis.
Read Announcement- Drug:
- Risankizumab-rzaa (SKYRIZI)
- Announced Date:
- March 27, 2026
- Indication:
- Moderate to Severe Crohn's Disease
Announcement
AbbVie announced new research across its dermatology portfolio to be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, March 27–31 in Denver, Colorado.
AI Summary
AbbVie said it will present new research across its dermatology portfolio at the 2026 American Academy of Dermatology (AAD) Annual Meeting, March 27–31 in Denver, Colorado. The company plans sessions that highlight clinical findings and patient-focused studies from its dermatology programs. AbbVie’s participation will showcase data intended for clinicians, patients, and researchers attending the meeting.
Key topics scheduled for presentation include long-term outcomes in psoriatic arthritis and atopic dermatitis, the quality-of-life impact of atopic dermatitis and psoriasis, and investigational Phase 3 data for upadacitinib (RINVOQ). AbbVie will also present information on SKYRIZI (risankizumab-rzaa) and RINVOQ U.S. uses and important safety information. The planned reports aim to provide new evidence that could help inform treatment decisions and improve patient care in dermatology.
Read Announcement
SKYRIZI (risankizumab-rzaa) PsA FDA Regulatory Timeline and Events
SKYRIZI (risankizumab-rzaa) PsA is a drug developed by AbbVie for the following indication: Active Psoriatic Arthritis.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- May 4, 2026
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie has announced two positive updates for Canadians living with UC, including those in Ontario and Alberta.
AI Summary
AbbVie announced two positive updates for Canadians living with ulcerative colitis (UC), including people in Ontario and Alberta. Crohn’s and Colitis Canada’s President and CEO Josh Berman said the changes aim to improve access to new treatment options, reduce barriers to advanced therapies, and give patients and their care teams more timely choices to manage this complex, lifelong disease. The announcements signal progress toward making additional UC therapies more available to affected patients across provinces.
Separately, AbbVie noted that SKYRIZI® is approved in Canada for adults with moderate to severe plaque psoriasis who need systemic therapy or phototherapy, and for adults with active psoriatic arthritis. SKYRIZI can be used alone or with a conventional non‑biologic disease‑modifying antirheumatic drug (cDMARD), such as methotrexate.
Read Announcement- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- April 27, 2026
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for SKYRIZI® (risankizumab-rzaa) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD).
AI Summary
AbbVie announced it has submitted an application to the U.S. Food and Drug Administration seeking approval for SKYRIZI® (risankizumab-rzaa) as a subcutaneous (SC) induction treatment for adult patients with moderately to severely active Crohn’s disease. The request is specifically for use of risankizumab-rzaa administered by SC injection during the induction phase of treatment.
The submission is supported by data from the Phase 3 pivotal AFFIRM study, which provided evidence on the medicine’s efficacy and safety in this patient group. If approved, adults with moderate to severe Crohn’s disease would have an additional induction treatment option with risankizumab-rzaa, potentially offering more flexibility in how therapy is started and managed.
SKYRIZI carries important safety information, including risks of allergic reactions and infections. Patients should consult their healthcare provider for full prescribing details and to discuss whether this treatment is appropriate for them.
Read Announcement- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- March 2, 2026
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).1
AI Summary
AbbVie announced positive topline results from the Phase 3 AFFIRM study, a randomized, placebo-controlled, double-blind trial evaluating risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adults with moderately to severely active Crohn’s disease. The announcement reports favorable efficacy and safety signals from the induction phase, supporting risankizumab’s potential benefit in this patient group.
The study enrolled a predominantly treatment-refractory population (65%); of those patients, half had failed two or more advanced therapies, 23% had previously failed ustekinumab, and 12% had failed a Janus kinase inhibitor (JAKi). Full results will be published in a medical journal and presented at upcoming medical congresses. AbbVie said detailed data on outcomes and safety will be shared when the complete analyses are available.Read Announcement
- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- November 28, 2025
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie announced two positive updates for Canadians living with ulcerative colitis (UC).
AI Summary
AbbVie announced two positive updates for Canadians living with ulcerative colitis (UC). Canada’s Drug Agency (CDA‑AMC) recommended SKYRIZI® (risankizumab), an IL‑23 inhibitor, for conditional reimbursement by public drug plans for adults with moderately to severely active UC who had an inadequate response, loss of response, or intolerance to conventional therapy, a biologic, or a JAK inhibitor.
The CDA‑AMC recommendation was informed by feedback from 25 Canadian clinicians and two patient organizations, including the GI Society and Crohn’s and Colitis Canada. In parallel, AbbVie completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA) and signed a Letter of Intent (LOI), a key step toward public plan listing and patient access.
AbbVie and clinical leaders said the updates could expand treatment choices and help eligible patients achieve remission and improve quality of life, addressing needs of the growing number of Canadians living with UC.
Read Announcement- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- July 26, 2024
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie announced that the European Commission has approved SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.3
Read Announcement- Drug:
- SKYRIZI (risankizumab-rzaa) PsA
- Announced Date:
- June 18, 2024
- Indication:
- Active Psoriatic Arthritis
Announcement
AbbVie announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.3 SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases.
AI Summary
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This approval makes SKYRIZI the first IL-23 specific inhibitor granted for both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease. In addition to these two conditions, the drug is now approved for four different immune-mediated inflammatory diseases.
The treatment has shown its ability to help patients achieve clinical remission and endoscopic improvement. SKYRIZI is given with a 12-week induction period followed by a maintenance phase, including a convenient home-use option with an on-body injector. AbbVie’s FDA approval paves the way for improved treatment options, supporting better and more lasting outcomes for people living with these chronic conditions.
Read Announcement
RINVOQ (upadacitinib) FDA Regulatory Timeline and Events
RINVOQ (upadacitinib) is a drug developed by AbbVie for the following indication: Moderate to Severe Atopic Dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- April 28, 2026
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (RINVOQ®) 15 mg, once daily, compared to adalimumab (HUMIRA®) 40 mg, every other week, in adult patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX) who had an inadequate response or intolerance to a TNF inhibitor (TNFi) other than adalimumab.
AI Summary
AbbVie announced positive topline results from the Phase 3b/4 SELECT-SWITCH study comparing upadacitinib (RINVOQ®) 15 mg once daily to adalimumab (HUMIRA®) 40 mg every other week in adults with moderate to severe rheumatoid arthritis on stable methotrexate who had an inadequate response or intolerance to a TNF inhibitor (other than adalimumab). The study found 43.3% of patients receiving upadacitinib achieved low disease activity (DAS28-CRP ≤ 3.2) versus 22.4% on adalimumab (p < 0.001). Remission rates (DAS28-CRP < 2.6) were 28.4% for upadacitinib versus 14.5% for adalimumab (p < 0.001). AbbVie described the topline findings as positive for efficacy; detailed safety data were not included in the summary provided.
Dr. Louis Bessette noted the results are highly relevant to Canadian rheumatology practice and can help guide treatment after TNFi failure. RINVOQ is approved in Canada for specified RA indications. Further full data and regulatory information were not included in the excerpt.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- February 3, 2026
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV).
AI Summary
AbbVie announced it has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of upadacitinib (RINVOQ®) 15 mg once daily for the treatment of adults and adolescents with non-segmental vitiligo (NSV). The submission is based on Phase 3 trial results comparing upadacitinib 15 mg to placebo.
The trials used two co-primary endpoints at week 48: T‑VASI50 (at least a 50% reduction in Total Vitiligo Area Scoring Index from baseline) and F‑VASI75 (at least a 75% reduction in Facial Vitiligo Area Scoring Index from baseline). These measures assess overall and facial repigmentation versus placebo.
Upadacitinib is not yet approved for NSV and its safety and efficacy for this use have not been evaluated by regulators. Important safety considerations include increased risk of infections, potential drug interactions (tell your healthcare provider about all medicines), and avoiding grapefruit during treatment.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- October 29, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ®;15 mg, once daily in adult and adolescent patients living with non-segmental vitiligo (NSV).1
AI Summary
AbbVie announced positive topline results from two replicate Phase 3 studies of upadacitinib (RINVOQ®; 15 mg once daily) in adult and adolescent patients with non-segmental vitiligo (NSV).
NSV causes symmetrical, bilateral white patches on the skin. In both studies, upadacitinib met its co-primary endpoints at week 48: at least a 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) and at least a 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) compared to placebo.
Key ranked secondary endpoints were also achieved, including a significant increase in the number of patients reaching a 50% reduction in facial vitiligo (F-VASI 50) at week 48 versus placebo.
The safety profile of upadacitinib was generally consistent with its approved uses. No new safety signals were observed. The most common treatment-emergent adverse events were upper respiratory tract infection, acne and nasopharyngitis, with similar rates of serious adverse events compared to placebo.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- August 27, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie today announced that Health Canada has issued a Notice of Compliance for RINVOQ® (upadacitinib) for the treatment of adults with giant cell arteritis (GCA), both used in combination with a tapering course of corticosteroids and as monotherapy following discontinuation of corticosteroids.4
AI Summary
AbbVie announced Health Canada issued a Notice of Compliance for RINVOQ® (upadacitinib) to treat adults with giant cell arteritis (GCA). This is the first oral advanced therapy approved in Canada for GCA patients. RINVOQ can be used alongside a tapering course of corticosteroids or as monotherapy after steroid discontinuation. GCA is a serious inflammation of arteries that affects older adults and can cause vision loss or stroke if not treated quickly.
This marks the eighth approved indication across rheumatology, gastroenterology, and dermatology. Approval is based on results from the Phase 3 SELECT-GCA trial, where 46.4% of patients taking RINVOQ plus a 26-week steroid taper achieved sustained remission through week 52, compared to 29.0% on placebo with a longer taper (p=0.002). Safety results were consistent with other approved uses. Health Canada’s decision highlights a new treatment option for Canadians living with GCA.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- August 21, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).1
AI Summary
AbbVie announced positive topline results from the second pivotal study of its Phase 3 UP-AA program of upadacitinib (RINVOQ®; 15 mg and 30 mg daily) in adult and adolescent patients with severe alopecia areata. Participants had a mean baseline SALT score of 84.0, indicating about 16% scalp hair coverage.
Both doses met the primary endpoint by week 24, with 45.2% (15 mg) and 55.0% (30 mg) achieving ≥ 80% scalp hair coverage (SALT ≤ 20) versus 1.5% on placebo (p < 0.001). Secondary endpoints included eyebrow and eyelash improvements and 35.2% (15 mg) and 45.8% (30 mg) reaching ≥ 90% scalp coverage (SALT ≤ 10).
No new safety signals emerged in the 24-week, placebo-controlled period. Serious adverse events were 1.9% (15 mg), 1.8% (30 mg), and 0.7% (placebo), with low discontinuations. Common side effects included respiratory infections, acne, and nasopharyngitis. These results match the first replicate study’s findings.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- July 30, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).1
AI Summary
AbbVie announced positive topline results from the first of two Phase 3 UP-AA studies evaluating upadacitinib (RINVOQ®, 15 mg and 30 mg once daily) in adults and adolescents with severe alopecia areata and a mean baseline SALT score of 83.8 (about 16% scalp hair). In Study 2, 44.6% and 54.3% of patients on 15 mg and 30 mg, respectively, achieved at least 80% scalp hair coverage (SALT ≤ 20) at week 24, versus 3.4% on placebo (p < 0.001).
Key secondary endpoints were met, including 36.0% and 47.1% achieving 90% hair coverage (SALT ≤ 10), complete scalp hair regrowth (SALT = 0), and eyebrow and eyelash improvements. The safety profile matched approved uses of upadacitinib, with no new safety signals. Serious adverse events were under 3%, and common side effects included acne, nasopharyngitis, and upper respiratory infections. Results from the second pivotal study are expected in the third quarter of 2025.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- April 29, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).1
AI Summary
AbbVie announced that the U.S. FDA has approved RINVOQ® (upadacitinib) 15 mg taken once daily for treating giant cell arteritis (GCA) in adults. GCA, also known as temporal arteritis, is an autoimmune disease affecting medium and large arteries and can lead to complications like vision loss if untreated. Notably, RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved for this condition in the U.S. The approval is supported by data from the Phase 3 SELECT-GCA clinical trial, which showed that a significant number of patients achieved sustained remission when RINVOQ was used alongside a tapered steroid regimen. This new option offers an alternative to long-term steroid use, potentially reducing the risk of steroid-related side effects while addressing an unmet need in the treatment of immune-mediated diseases.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- April 8, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients.
AI Summary
AbbVie announced that the European Commission has granted marketing authorization for RINVOQ® (upadacitinib; 15 mg once daily) to treat giant cell arteritis (GCA) in adult patients. This approval marks RINVOQ as the first and only oral Janus kinase (JAK) inhibitor approved in the European Union for this condition.
The decision is supported by data from the pivotal Phase 3 SELECT-GCA clinical trial, which demonstrated that RINVOQ could achieve sustained remission, reduce disease flares, and lower overall steroid exposure. GCA is an autoimmune disease that causes inflammation of large and medium arteries, often leading to symptoms such as headaches, jaw pain, and a risk of sudden vision loss. With this new authorization, patients and physicians in the EU now have a promising, advanced treatment option, addressing a significant unmet need in managing this challenging condition.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- February 28, 2025
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with GCA.
AI Summary
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the approval of upadacitinib (RINVOQ® 15 mg once daily) to treat adult patients with giant cell arteritis (GCA). The recommendation is based on promising results from the pivotal Phase 3 SELECT-GCA trial, where patients achieved sustained remission, had fewer disease flares, and required less steroid use. GCA is a serious inflammatory disease that can lead to severe complications such as blindness, stroke, or aortic aneurysm if untreated. With this potential approval, upadacitinib would be the first and only oral advanced therapy available for GCA, marking an important milestone in improving treatment options for patients. The final decision by the European Commission is expected in the first half of 2025.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- July 12, 2024
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
AI Summary
AbbVie announced it has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication for upadacitinib (RINVOQ®; 15 mg taken once daily). The submission seeks to expand the use of the drug for treating adult patients with giant cell arteritis (GCA), an autoimmune condition that affects medium and large arteries and can lead to serious symptoms such as headaches, jaw pain, and vision problems, including potentially permanent vision loss.
This move is supported by promising data from the Phase 3 SELECT-GCA study, where upadacitinib, given with a tapering regimen of steroids over 26 weeks, achieved sustained remission. AbbVie’s filing represents a significant step to offer patients with GCA a potential alternative treatment, aiming to reduce reliance on glucocorticoids and improve quality of life.
Read Announcement
TrenibotE FDA Regulatory Events
TrenibotE is a drug developed by AbbVie for the following indication: For the Treatment of Glabellar Lines.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TrenibotE
- Announced Date:
- April 23, 2026
- Indication:
- For the Treatment of Glabellar Lines
Announcement
AbbVie announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration.
AI Summary
AbbVie announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin serotype E noted for rapid onset and short duration. The FDA’s CRL requested additional information specifically about manufacturing processes. Importantly, the letter did not identify any safety or efficacy concerns and did not request additional clinical studies.
AbbVie said it is confident it can address the FDA’s manufacturing comments promptly and expects to submit a thorough response in the coming months. The company plans to work closely with regulators and believes the issues can be resolved through documentation and process detail rather than new trials. Regulatory reviews for TrenibotE in other countries are continuing and are progressing as expected.
Read Announcement- Drug:
- TrenibotE
- Announced Date:
- April 24, 2025
- Indication:
- For the Treatment of Glabellar Lines
Announcement
AbbVie announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.
AI Summary
AbbVie announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) to treat moderate to severe glabellar lines. TrenibotE is a first-in-class neurotoxin that offers a rapid onset of action, with effects seen as early as 8 hours after treatment, and a shorter duration of effect lasting 2–3 weeks. If approved, it will be the first serotype E neurotoxin available for aesthetic treatments, providing a new option for patients who may be hesitant to try traditional neurotoxins because of concerns about looking unnatural.
The submission is backed by data from over 2,100 patients, with Phase 3 studies meeting all primary and secondary endpoints. This innovative treatment could help transform the facial aesthetics market by offering a faster-acting, temporary alternative for those seeking a trial before more established options.
Read Announcement
ELAHERE FDA Regulatory Timeline and Events
ELAHERE is a drug developed by AbbVie for the following indication: For the Treatment of Certain Adult Ovarian Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ELAHERE
- Announced Date:
- April 13, 2026
- Indication:
- For the Treatment of Certain Adult Ovarian Cancer
Announcement
AbbVie announced that late-breaking results from the Phase 2 IMGN853-0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting (San Juan, Puerto Rico; April 10-13, 2026).
AI Summary
AbbVie announced that late‑breaking results from the Phase 2 IMGN853‑0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico (April 10–13, 2026). The presentation is expected to share new data on mirvetuximab soravtansine‑gynx given with carboplatin, followed by mirvetuximab soravtansine‑gynx continuation, for folate receptor‑alpha (FRα)‑expressing recurrent platinum‑sensitive ovarian cancer (PSOC).
The study’s primary endpoint was confirmed objective response rate (ORR) after six cycles in the ≥50% FRα subgroup. A key secondary endpoint was ORR after six cycles in the overall population (FRα ≥25%), with additional secondary measures including duration of response (DoR), progression‑free survival (PFS), and overall survival (OS).
AbbVie said the oral session will highlight efficacy and safety findings. Use of this combination in FRα‑expressing recurrent PSOC is not approved in the U.S., the E.U., or elsewhere, and its safety and efficacy have not been established. More trial details are available at clinicaltrials.gov.
Read Announcement- Drug:
- ELAHERE
- Announced Date:
- October 30, 2025
- Indication:
- For the Treatment of Certain Adult Ovarian Cancer
Announcement
AbbVie announced that Canada's Drug Agency (CDA-AMC), formerly CADTH, has recommended that ELAHERE® (mirvetuximab soravtansine for injection), an antibody-drug conjugate (ADC), be reimbursed with conditions, for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Read Announcement- Drug:
- ELAHERE
- Announced Date:
- November 18, 2024
- Indication:
- For the Treatment of Certain Adult Ovarian Cancer
Announcement
AbbVie announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
AI Summary
AbbVie announced that the European Commission has granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for adult patients with folate receptor‐alpha (FRα) positive, platinum‐resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. This approval makes ELAHERE the first and only FRα‐directed antibody drug conjugate (ADC) available in the European Union, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland.
ELAHERE offers a new, targeted treatment option for patients with limited alternatives, backed by data from a Phase 3 study showing improved outcomes compared to standard chemotherapy. Patients are identified as eligible through the companion diagnostic VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, ensuring that the treatment is directed to those most likely to benefit.
Read Announcement- Drug:
- ELAHERE
- Announced Date:
- September 20, 2024
- Indication:
- For the Treatment of Certain Adult Ovarian Cancer
Announcement
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE®) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens.
AI Summary
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for mirvetuximab soravtansine (ELAHERE®). This decision supports the marketing authorization of the treatment for a specific group of adult patients: those with folate receptor alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have already received one to three prior treatment regimens. The positive opinion is based on results from the global Phase 3 MIRASOL clinical trial, which demonstrated promising efficacy and safety outcomes for patients when other platinum-based therapies had failed. AbbVie expressed hope that this recommendation will soon lead to the availability of mirvetuximab soravtansine in the European Union, providing a much-needed new option for patients facing difficult-to-treat ovarian cancer. The final European Commission decision is expected later this year.
Read Announcement
ABBV-295 FDA Regulatory Events
ABBV-295 is a drug developed by AbbVie for the following indication: Long-Acting Amylin Analog, in Adults.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABBV-295
- Announced Date:
- March 9, 2026
- Indication:
- Long-Acting Amylin Analog, in Adults
Announcement
AbbVie announced positive topline results1 from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2.
AI Summary
AbbVie announced positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study of subcutaneous ABBV-295, tested in adults with a mean BMI under 30 kg/m2. ABBV-295 is a long-acting amylin analog and works differently from incretin-based drugs like GLP-1 and GIP agonists. Study enrollment was mostly male (88.3%). Doses from 2 to 14 mg, with different titrations and dosing schedules, were evaluated. The trial measured safety, tolerability, pharmacokinetics, and pharmacodynamics.
ABBV-295 produced clinically meaningful weight loss: weekly dosing showed least-squares mean reductions of about −7.75% to −9.79% at week 12, and every-other-week or monthly dosing (after week 5) showed −7.86% to −9.73% at week 13. The drug was generally well tolerated across doses, with no serious adverse events reported. The most common side effects were mild gastrointestinal issues, mainly during the first six weeks. These results support continued development of ABBV-295 as a potentially differentiated option for chronic weight management.
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VENCLEXTA (venetoclax) FDA Regulatory Events
VENCLEXTA (venetoclax) is a drug developed by AbbVie for the following indication: Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VENCLEXTA (venetoclax)
- Announced Date:
- February 20, 2026
- Indication:
- Multiple Myeloma
Announcement
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL).
AI Summary
AbbVie announced that the U.S. Food and Drug Administration approved a supplemental new drug application (sNDA) for the combination of VENCLEXTA (venetoclax) and acalabrutinib to treat previously untreated adult patients with chronic lymphocytic leukemia (CLL). The approval applies to front-line use, making this combination available as an option for clinicians and patients in the United States.
This regimen is the first and only all-oral, fixed-duration first-line treatment for previously untreated CLL. It combines two classes of targeted oral medicines—a BCL-2 inhibitor (venetoclax) and a BTK inhibitor (acalabrutinib)—and offers a time-limited approach that can give patients periods off therapy. The approval broadens first-line choices and aligns with current standards of care by providing a new targeted option that may reduce long-term continuous treatment.
VENCLEXTA is developed by AbbVie with Roche and is jointly commercialized by AbbVie and Genentech in the U.S. Patient groups have welcomed the approval as an important addition to CLL treatment options.Read Announcement
BOTOX (onabotulinumtoxinA) FDA Regulatory Timeline and Events
BOTOX (onabotulinumtoxinA) is a drug developed by AbbVie for the following indication: Upper Limb Spasticity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- January 21, 2026
- Indication:
- Upper Limb Spasticity
Announcement
AEON Biopharma, Inc. reported on two separate positive events for the Company
AI Summary
AEON Biopharma reported two positive developments today. First, the company held its scheduled BPD Type 2a meeting with the U.S. Food and Drug Administration regarding ABP-450, its biosimilar to BOTOX. AEON is now awaiting the FDA’s official meeting minutes, expected in about 30 days, which the company says will help inform the next steps in ABP-450’s development.
Second, AEON’s shareholders approved the transactions announced in November, including the remaining issuances tied to its PIPE financing and the exchange of convertible notes held by Daewoong. The Daewoong note exchange closed today, which AEON says will substantially reduce outstanding debt and simplify its capital structure. AEON expects to complete the second closing of the PIPE financing on or around January 27, 2026, subject to customary closing conditions, and said these actions strengthen its balance sheet and support continued work on the biosimilar program.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- November 12, 2025
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announced it will present data highlighting efficacy, safety and patient-reported outcomes across its portfolio during the 2025 American Society of Dermatologic Surgery (ASDS) Annual Meeting, November 13-16, 2025, in Chicago, Illinois.
AI Summary
Allergan Aesthetics, an AbbVie company, will present clinical and patient-reported data at the 2025 American Society of Dermatologic Surgery (ASDS) Annual Meeting, November 13–16 in Chicago. The company will show oral and video poster presentations, expert panels, and symposiums that highlight efficacy, safety and patient satisfaction across its aesthetic portfolio.
A total of 17 abstracts were accepted, including three oral presentations in the Cosmetic "Top Ten" Session. These include Phase 3 results on trenibotulinumtoxinE for glabellar lines (safety and efficacy), Phase 3 data on patient-reported satisfaction and natural-looking results with fast-acting trenibotulinumtoxinE, and Phase 4 findings showing high patient satisfaction after 64 units of BOTOX® Cosmetic for upper facial lines in a diverse population.
An expert panel will review the new Hyaluronic Acid Injectable Fillers Report and real-world satisfaction data. Other topics include sequential use of toxins, long-term repeat BOTOX® use, SKINVIVE by JUVÉDERM® for the neck, and surveys on aesthetic trends after medical weight loss.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- October 21, 2025
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announced this year's grant recipients of The Confidence Project: Empowering Women Entrepreneurs.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- October 9, 2025
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announced the rollout of SkinMedica®'s reimagined packaging—a modernized look that elevates the consumer experience while advancing sustainability.
AI Summary
Allergan Aesthetics, an AbbVie company, has unveiled a reimagined look for its SkinMedica® line. The refreshed packaging features a clean, modern layout with a new logo, luxe copper accents, and intuitive navigation cues. This design is meant to help consumers find and choose the right products more easily while giving SkinMedica® a more sophisticated appearance.
Alongside the updated style, the brand prioritized greener materials. Ninety percent of the packaging components by weight and all secondary cartons are now fully recyclable. These changes are projected to cut landfill waste by 71 percent—over 550,000 pounds each year—without compromising product performance or safety.
Launching with the new design is the SkinMedica® HA5® Hydra Collagen Water Burst Moisturizer. Its advanced formula blends five types of hyaluronic acid with vegan hydra collagen and a microbiome barrier complex. This moisturizer delivers up to 24 hours of lightweight, bouncy hydration while supporting the skin’s natural barrier and healthy microbiome.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- October 6, 2025
- Indication:
- Upper Limb Spasticity
Announcement
AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor.
AI Summary
AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating onabotulinumtoxinA (BOTOX®) versus placebo for upper limb essential tremor. The study met its primary endpoint, showing a statistically significant improvement in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score at week 18 (mean change –2.61 vs. –1.61; p=0.029). All six secondary endpoints, including activities of daily living and tremor severity measures, were also met.
Safety findings were consistent with the known BOTOX® profile. Muscular weakness was the most common adverse event, occurring in 24.5% of patients treated with onabotulinumtoxinA versus 2.3% for placebo. Most cases were localized, transient and rated mild to moderate.
With no new pharmacological treatments approved for essential tremor in over 30 years, these results offer a promising new approach. Detailed data will be presented at the International Congress of Parkinson’s Disease and Movement Disorders® on October 8, 2025.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- May 1, 2025
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announced BOTOX® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs.
AI Summary
Allergan Aesthetics, an AbbVie company, has announced the launch of The Confidence Project: Empowering Women Entrepreneurs. Through this initiative, BOTOX® Cosmetic aims to help close the Confidence Gap by providing enhanced support to women business owners. This year’s program offers 250 entrepreneurs access to a “Boostcamp” in partnership with Hello Alice, an online platform designed to help businesses grow. The intensive course will equip participants with skill-building, mentorship, and networking opportunities. After completing the Boostcamp, the entrepreneurs can pitch their business ideas to a panel of aesthetic entrepreneurs and business leaders from Allergan Aesthetics and Hello Alice for a chance to win one of 20 grants of $20,000 each. The initiative reflects BOTOX® Cosmetic’s commitment to empowering women by offering key resources and funding to help them pursue and achieve their entrepreneurial dreams.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- September 24, 2024
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announce the next exciting phase of its 2024 BOTOX® Cosmetic grant program dedicated to uplifting women entrepreneurs.
AI Summary
Allergan Aesthetics, an AbbVie company, has launched the next exciting phase of its 2024 BOTOX® Cosmetic grant program to help uplift women entrepreneurs. Through this initiative, 20 inspiring women will each receive a $25,000 grant along with support to grow their businesses. Central to this phase are crowdfunding campaigns, which give the community an opportunity to back these talented entrepreneurs.
The program is designed to close the "Confidence Gap" by providing essential resources in a field where women-led startups typically receive less than three percent of venture capital funding. In addition to financial support, the initiative offers transformative bootcamps, one-on-one coaching, and participation in an online accelerator program with IFundWomen. This combined support empowers the women with the skills needed for better brand building, strategic planning, and marketing, ultimately driving their success and innovation in business.
Read Announcement- Drug:
- BOTOX (onabotulinumtoxinA)
- Announced Date:
- September 11, 2024
- Indication:
- Upper Limb Spasticity
Announcement
Allergan Aesthetics, an AbbVie company announced that BOTOX® Cosmetic (onabotulinumtoxinA) is now available for the treatment of masseter muscle prominence (MMP) in China.
AI Summary
Allergan Aesthetics, an AbbVie company, announced that BOTOX® Cosmetic is now available in China for the treatment of masseter muscle prominence (MMP). MMP is a condition where the masseter muscles become overly developed, resulting in a wider, square-shaped lower face. This new use of BOTOX® Cosmetic offers a minimally invasive option to help relax these muscles, leading to a slimmer and more defined jawline. The approval is backed by robust clinical trials that demonstrated significant improvements, with patients experiencing a noticeable reduction in facial width that lasted approximately 6-9 months.
Building on its well-established safety profile and established dosing guidelines, Allergan Aesthetics plans to expand the use of BOTOX® Cosmetic for MMP to new global markets. This strategic move addresses a high unmet need among patients looking for non-surgical treatments to reshape the lower face and enhance their facial aesthetics.
Read Announcement
MAVIRET FDA Regulatory Events
MAVIRET is a drug developed by AbbVie for the following indication: Treatment of Acute Hepatitis C Virus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MAVIRET
- Announced Date:
- January 6, 2026
- Indication:
- Treatment of Acute Hepatitis C Virus
Announcement
AbbVie announced lth Canada has approved MAVIRET (glecaprevir/pibrentasvir tablets) for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and pediatric patients 3 years of age and older and weighing ≥ 12 kg.2
AI Summary
AbbVie announced Health Canada approved MAVIRET (glecaprevir/pibrentasvir) to treat acute and chronic hepatitis C in adults and in pediatric patients aged 3 years and older weighing ≥ 12 kg. It is the first and only oral eight‑week pan‑genotypic option in Canada.
The approval came via Health Canada’s Priority Review based on the Phase 3 M20‑350 study, a single‑arm trial of 286 treatment‑naïve adults with acute HCV. Patients took MAVIRET once daily for eight weeks and were followed 12 weeks after treatment; the trial showed high efficacy by sustained virologic response 12 weeks post‑treatment (SVR12).
Health officials say the approval lets providers start treatment as soon as a diagnosis is made, supporting treatment‑as‑prevention and WHO elimination goals. Common side effects include diarrhea, fatigue and nasopharyngitis. MAVIRET is supplied as three oral tablets for adults and coated granules in sachets for children.
Read Announcement
EPKINLY® (epcoritamab-bysp) FDA Regulatory Timeline and Events
EPKINLY® (epcoritamab-bysp) is a drug developed by AbbVie for the following indication: To Treat Patients with Relapsed or Refractory Follicular Lymphoma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- December 7, 2025
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
Genmab A/S announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
AI Summary
Genmab reported primary results from the Phase 3 EPCORE FL-1 trial testing fixed‑duration epcoritamab (EPKINLY) combined with rituximab and lenalidomide (EPKINLY + R2) versus R2 alone in adults with relapsed or refractory follicular lymphoma. The randomized study enrolled 243 patients to the combination and 245 to R2, with a median follow‑up of 14.8 months. Dual primary endpoints included progression‑free survival (PFS) and overall response rate (ORR) assessed by an independent review committee.
The trial found a 79% reduction in risk of disease progression or death with EPKINLY + R2 (HR 0.21; 95% CI 0.14–0.31; p<0.0001). ORR was 95% versus 79% for R2 (p<0.0001). Complete response rates were 83% versus 50%, and 12‑month duration of response was 89% versus 49% for the combination and R2, respectively.
Safety was consistent with known profiles. Grade 3–4 adverse events occurred in 90.1% versus 67.6%, mainly more neutropenia (68.7% vs 42.0%) and infections (33.3% vs 15.1%). Fatal events were 1.6% versus 3.8%. Cytokine release syndrome was mostly low grade (26.3%; 21.2% Grade 1, 5.3% Grade 2). Results were presented at ASH and published in The Lancet.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- February 20, 2025
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
Genmab A/S that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.
AI Summary
Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for treating patients with relapsed or refractory follicular lymphoma (Grades 1 to 3A) who have had two or more prior therapies. This approval marks a significant milestone as EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously to be approved in Japan for both R/R follicular lymphoma and R/R large B-cell lymphomas. This dual indication aims to address the high unmet need for effective treatments among patients whose cancer returns or stops responding to current therapies. The approval was based on positive clinical data from Phase 1/2 trials, where lasting responses and manageable side effects were observed, highlighting EPKINLY’s potential as an important option for patients facing limited treatment alternatives.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- August 15, 2024
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
AbbVie announced that EPKINLY is now listed on the Ontario Health (Cancer Care Ontario) formulary under the NDFP (New Drug Funding Program) and the HCTFP (High Cost Therapy Funding Program) programs1 and the Régie de l'assurance maladie du Québec (RAMQ) Liste des médicaments - Établissements2 for the treatment of adult patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.
AI Summary
AbbVie has announced that its cancer therapy EPKINLY is now included on the Ontario Health (Cancer Care Ontario) formulary under the New Drug Funding Program (NDFP) and the High Cost Therapy Funding Program (HCTFP). It is also listed on the Régie de l'assurance maladie du Québec’s (RAMQ) Liste des médicaments – Établissements. This inclusion provides new access for adult patients who have Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
These patients must have undergone two or more lines of systemic therapy and either previously received or be unable to receive CAR-T cell therapy. The decision to list EPKINLY on these formularies aims to give more patients an effective treatment option for this aggressive form of lymphoma, potentially improving their outcomes with a targeted immunotherapy approach.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- June 26, 2024
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
AI Summary
AbbVie announced that the FDA has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody given by subcutaneous injection for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy. This Accelerated Approval is based on data showing strong overall response rates and durable patient responses. The approval marks a significant step for patients with FL, a form of non-Hodgkin’s lymphoma that is typically incurable using current treatments, leaving many with limited options after relapse.
EPKINLY’s subcutaneous dosing offers a convenient alternative as it can be administered outside of a hospital setting using a 3-step dosing regimen, which helps manage side effects like cytokine release syndrome. AbbVie believes this treatment could become a core option for multiple B-cell cancers moving forward.
Read Announcement
LUPRON DEPOT FDA Regulatory Events
LUPRON DEPOT is a drug developed by AbbVie for the following indication: Treatment of Advanced Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LUPRON DEPOT
- Announced Date:
- November 17, 2025
- Indication:
- Treatment of Advanced Prostate Cancer
Announcement
AbbVie announced today that a new 6-month 45mg LUPRON DEPOT® (leuprolide acetate for extended-release injectable suspension) strength has received Health Canada approval for the treatment of advanced prostate cancer.
AI Summary
AbbVie announced that Health Canada has approved a new 6-month, 45 mg strength of LUPRON DEPOT (leuprolide acetate for extended‑release injectable suspension) for treating advanced prostate cancer. With this approval, LUPRON DEPOT is now offered in four dosing options: 7.5 mg (1‑month), 22.5 mg (3‑month), 30 mg (4‑month) and 45 mg (6‑month), giving doctors and patients more flexibility in scheduling injections.
Clinicians say the longer-duration option can reduce the treatment and travel burden for patients, helping simplify care and potentially improving quality of life. Prostate cancer is the most common cancer in Canadian men, and advancing treatment options aims to better meet patient needs.
AbbVie notes LUPRON DEPOT has been used in Canada since 1989 and works as a GnRH analog to lower sex-hormone production. The company framed the approval as part of its ongoing commitment to support people with advanced prostate cancer.Read Announcement
HUMIRA (adalimumab) FDA Regulatory Events
HUMIRA (adalimumab) is a drug developed by AbbVie for the following indication: Severely active ulcerative colitis in pediatric.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HUMIRA (adalimumab)
- Announced Date:
- October 20, 2025
- Indication:
- Severely active ulcerative colitis in pediatric
Announcement
AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (RINVOQ®) 15 mg, once daily, compared to adalimumab (HUMIRA®) 40 mg, every other week, in adult patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX) who had an inadequate response or intolerance to a TNF inhibitor (TNFi) other than adalimumab.1
AI Summary
AbbVie today reported positive topline results from the Phase 3b/4 SELECT-SWITCH study comparing upadacitinib (RINVOQ®) 15 mg once daily with adalimumab (HUMIRA®) 40 mg every other week in adults with moderate to severe rheumatoid arthritis on stable methotrexate who had an inadequate response or intolerance to a TNF inhibitor other than adalimumab.
At week 12—the primary analysis—43.3% of patients receiving upadacitinib achieved low disease activity (DAS28-CRP ≤ 3.2) versus 22.4% on adalimumab (p < 0.001). In the ranked secondary endpoint of remission (DAS28-CRP < 2.6), 28.4% versus 14.5% of patients met criteria (p < 0.001). Upadacitinib also outperformed adalimumab on most other ranked endpoints. SELECT-SWITCH is the first head-to-head trial to compare TNF inhibitor cycling with switching to a JAK inhibitor in this patient population.
The safety profile of upadacitinib was consistent with previous studies, with no new risks identified over 12 weeks. Full results will be published in a peer-reviewed journal.
Read Announcement
Temab-A FDA Regulatory Events
Temab-A is a drug developed by AbbVie for the following indication: Advancing Targeted Therapies for Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Temab-A
- Announced Date:
- October 13, 2025
- Indication:
- Advancing Targeted Therapies for Solid Tumors
Announcement
AbbVie announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany.
AI Summary
AbbVie will unveil new data from its antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, October 17–21 in Berlin, Germany. The data include results for telisotuzumab adizutecan (Temab-A), a c-Met–directed ADC tested in advanced colorectal cancer, MET-amplified solid tumors, and pancreatic ductal adenocarcinoma. Temab-A showed responses in patients who had received multiple prior therapies, suggesting its potential as a targeted treatment for hard-to-treat cancers.
AbbVie will also present findings on ABBV-706, an SEZ6-targeting ADC studied in relapsed/refractory small cell lung cancer, highlighting its effects on tumor markers and survival. These presentations reinforce AbbVie’s commitment to expanding treatment options through its growing ADC portfolio and will cover safety, efficacy, and biomarker analyses in detailed oral and poster sessions.
Read Announcement
ABBV-RGX-314 FDA Regulatory Events
ABBV-RGX-314 is a drug developed by AbbVie for the following indication: In patients with wet AMD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABBV-RGX-314
- Announced Date:
- October 9, 2025
- Indication:
- In patients with wet AMD
Announcement
REGENXBIO Inc. announced that it will present interim data from the Phase II ALTITUDE® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy of Ophthalmology 2025 Annual Meeting.
AI Summary
REGENXBIO Inc. will share interim results from its Phase II ALTITUDE® trial at the American Academy of Ophthalmology 2025 Annual Meeting. These data look at suprachoroidal delivery of surabgene lomparvovec for people with diabetic retinopathy.
Surabgene lomparvovec, also called ABBV-RGX-314 or sura-vec, is a one-time gene therapy made with AbbVie. The treatment uses an AAV8 vector to block vascular endothelial growth factor, which causes leaky blood vessels and fluid buildup in the retina.
Highlights 2-year results in non-proliferative diabetic retinopathy. Dr. Charles C. Wykoff from Retina Consultants of Texas will present on October 17 at 4:46 p.m. ET during the “Late Breaking Developments, Part I” session.
This study could lead to a first-in-class treatment for diabetic retinopathy. The gene therapy is under investigation and not yet approved. REGENXBIO aims to offer patients a long-lasting option with one dose.
Read Announcement- Drug:
- ABBV-RGX-314
- Announced Date:
- January 13, 2025
- Indication:
- In patients with wet AMD
Announcement
AbbVie and REGENXBIO Inc. announced updates to the ABBV-RGX-314 clinical program.
AI Summary
AbbVie and REGENXBIO Inc. have updated the clinical program for their investigational gene therapy, ABBV-RGX-314. This program is exploring new treatment methods for two serious retinal diseases: wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR). For wet AMD, pivotal trial data on the safety and efficacy of the subretinal delivery of ABBV-RGX-314 are expected in 2026. This innovative approach could potentially reduce the need for frequent injections that many patients currently depend on.
For diabetic retinopathy, the companies plan a Phase 3 clinical program that will use the SCS Microinjector® for suprachoroidal delivery. This method aims to ease treatment burdens by providing a one-time therapy option. Both companies are optimistic that these advancements could lead to significant improvements in managing these vision-threatening conditions.
Read Announcement
CADENZA FDA Regulatory Events
CADENZA is a drug developed by AbbVie for the following indication: Treat Rare Cancer with Limited Treatment Options.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CADENZA
- Announced Date:
- September 30, 2025
- Indication:
- Treat Rare Cancer with Limited Treatment Options
Announcement
AbbVie announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
AI Summary
AbbVie announced it has submitted a new Biologics License Application (BLA) to the U.S. Food and Drug Administration for approval of investigational Pivekimab sunirine (PVEK) to treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). BPDCN is a rare and aggressive blood cancer that shows features of both leukemia and lymphoma. Patients often develop skin lesions and the disease can spread to the bone marrow, central nervous system, and lymph nodes. Current first-line treatment usually involves intensive chemotherapy and a stem cell transplant, but many patients still need more effective options.
The BLA is based on data from the global Phase 1/2 CADENZA trial, which tested PVEK’s safety and effectiveness in patients with BPDCN. PVEK is an antibody-drug conjugate that targets the CD123 protein overexpressed on BPDCN cells. By binding to CD123, PVEK delivers a potent anti-cancer payload directly into the tumor cells.
“Meaningful innovations in cancer research and treatment are happening every day,” said Roopal Thakkar, AbbVie’s executive vice president and chief scientific officer. “We look forward to the next steps in the regulatory process for our first blood-cancer ADC and how it may advance treatment for patients living with BPDCN.”
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Tavapadon FDA Regulatory Timeline and Events
Tavapadon is a drug developed by AbbVie for the following indication: Parkinson’s disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tavapadon
- Announced Date:
- September 26, 2025
- Indication:
- Parkinson’s disease
Announcement
AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.
AI Summary
AbbVie (NYSE: ABBV) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once-daily oral treatment for Parkinson’s disease.
Support comes from the Phase 3 TEMPO program, which ran two trials (TEMPO-1 and TEMPO-2) in early Parkinson’s and one adjunctive trial (TEMPO-3) with levodopa. Early PD patients showed significant gains on the MDS-UPDRS Parts II and III. In the adjunctive trial, patients had more “on” time without troublesome dyskinesia. An open-label extension (TEMPO-4) is assessing long-term effects.
Most side effects in the TEMPO trials were mild or moderate, such as nausea, headache, dizziness, and dyskinesia. If approved, tavapadon would offer a new once-daily oral option and strengthen AbbVie’s leadership in Parkinson’s disease treatment.
Read Announcement- Drug:
- Tavapadon
- Announced Date:
- December 9, 2024
- Indication:
- Parkinson’s disease
Announcement
AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease.
AI Summary
AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy for early Parkinson’s disease. Tavapadon is the first and only D1/D5 partial agonist under investigation for Parkinson’s, offering a once-daily treatment option. The trial met its primary endpoint by showing a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score after 26 weeks.
In addition, the TEMPO-2 trial achieved its key secondary endpoint with a marked improvement in motor aspects of daily activities. These results, along with data from other Phase 3 TEMPO trials, support tavapadon’s potential as a first-in-class therapy. AbbVie plans to submit a New Drug Application (NDA) to the FDA in 2025.
Read Announcement - Drug:
- Tavapadon
- Announced Date:
- September 26, 2024
- Indication:
- Parkinson’s disease
Announcement
AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment for Parkinson's disease.
AI Summary
AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s disease. The study evaluated two fixed doses (5 mg and 15 mg, taken once daily) and showed that patients experienced a statistically significant improvement compared to placebo. Specifically, the trial met its primary endpoint with notable reductions in the MDS-UPDRS Parts II and III combined score at week 26, as well as a key secondary endpoint that demonstrated meaningful improvement in daily motor activities.
Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment option for Parkinson’s disease. The positive results, along with a consistent safety profile where most adverse events were mild to moderate, mark an important step forward in developing new treatment options for early-stage Parkinson’s disease.
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SKINVIVE FDA Regulatory Events
SKINVIVE is a drug developed by AbbVie for the following indication: Advancing Global Skin Quality.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SKINVIVE
- Announced Date:
- September 23, 2025
- Indication:
- Advancing Global Skin Quality
Announcement
Allergan Aesthetics, an AbbVie company announced the roll-out of SKINVIVE by JUVÉDERM® in 35 additional markets this year bringing the total to 57 globally in 2025. This expansion underscores Allergan Aesthetics' global strategic commitment to enhancing skin quality worldwide.
AI Summary
Allergan Aesthetics, an AbbVie company, will launch SKINVIVE by JUVÉDERM in 35 more markets this year, bringing the global total to 57 launches in 2025. This expansion highlights its commitment to improving skin quality worldwide.
SKINVIVE is a hydrating injectable that delivers long-lasting moisture and smoothness to the face in a single treatment. It is the longest-lasting hydrating injectable available, offering deep skin hydration valued across all ages.
“This rollout marks an exciting new era for Allergan Aesthetics, with greater emphasis on skin quality,” said Mark Wilson, SVP, International Allergan Aesthetics. He noted the company is evolving its portfolio with innovative injection techniques, the AA Signature approach, and strategic launches to help practitioners achieve optimal results.
With the skin quality market valued at $5.2 billion, patients now favor health-focused, natural-looking enhancements over dramatic changes. Allergan Aesthetics’ global expansion of SKINVIVE and its holistic AA Signature strategy demonstrate its dedication to healthier, more youthful-looking skin.
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Venetoclax FDA Regulatory Events
Venetoclax is a drug developed by AbbVie for the following indication: For Newly Diagnosed Higher-Risk Myelodysplastic Syndromes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- venetoclax
- Announced Date:
- July 29, 2025
- Indication:
- For Newly Diagnosed Higher-Risk Myelodysplastic Syndromes
Announcement
AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.
AI Summary
AbbVie announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for a fixed-duration, all-oral combination of VENCLEXTA® (venetoclax) and acalabrutinib. This regimen is intended for adults with previously untreated chronic lymphocytic leukemia (CLL).
The sNDA is supported by results from the Phase 3 AMPLIFY trial, which showed a statistically significant improvement in progression-free survival compared to standard chemoimmunotherapy. Patients receiving the oral combination had a 35 percent lower risk of disease progression or death.
If approved, this treatment would represent the first time-limited, all-oral VENCLEXTA regimen in frontline CLL care. The approach may allow patients to pause therapy after a set treatment period, potentially improving quality of life and disease management.
AbbVie believes this novel fixed-duration strategy could change practice in frontline CLL by offering another effective, time-limited option for newly diagnosed patients.
Read Announcement- Drug:
- venetoclax
- Announced Date:
- June 16, 2025
- Indication:
- For Newly Diagnosed Higher-Risk Myelodysplastic Syndromes
Announcement
AbbVie announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772.
AI Summary
AbbVie announced that its global Phase 3 VERONA trial, which studied the combination of venetoclax and azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS), did not meet its primary endpoint of improving overall survival. The trial reported a hazard ratio of 0.908 with a stratified log-rank p-value of 0.3772, showing that the treatment did not provide a statistically significant benefit in extending patient survival.
Despite the outcome, no new safety signals were observed, and the results from the VERONA trial will be shared at a future medical congress or publication. Patients who participated in the trial will be informed by their treating physician. The trial results do not affect any current approved indications for venetoclax.
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Atogepant FDA Regulatory Events
Atogepant is a drug developed by AbbVie for the following indication: Episodic Migraine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Atogepant
- Announced Date:
- June 18, 2025
- Indication:
- Episodic Migraine
Announcement
AbbVie announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1
AI Summary
AbbVie announced positive topline results from the Phase 3 TEMPLE study, which compared atogepant (QULIPTA®/AQUIPTA®) 60 mg once daily with the highest tolerated dose of topiramate for migraine prevention in adults with four or more migraine days per month. The study showed that fewer patients on atogepant discontinued treatment because of side effects—12.1% compared to 29.6% with topiramate. In addition, all six secondary endpoints were met, including a significant improvement in clinical efficacy. Notably, 64.1% of patients on atogepant achieved at least a 50% reduction in monthly migraine days during months 4 to 6, compared to 39.3% on topiramate.
These promising results support the use of atogepant as a well-tolerated and effective preventive treatment for migraine, reinforcing current recommendations for using CGRP receptor antagonists as a first-line option for managing this debilitating condition.
Read Announcement- Drug:
- Atogepant
- Announced Date:
- December 19, 2024
- Indication:
- Episodic Migraine
Announcement
AbbVie announced today that atogepant and onabotulinumtoxinA have received strong recommendations in the newly updated CHS Migraine Prevention Guideline: atogepant is strongly recommended in the treatment of episodic and chronic migraine, and onabotulinumtoxinA, in the treatment of chronic migraine (please refer to the guideline for the full recommendations).
AI Summary
AbbVie announced that the updated Canadian Headache Society (CHS) Migraine Prevention Guideline has given strong recommendations to two key treatments. Atogepant is now strongly recommended for treating both episodic and chronic migraine, while onabotulinumtoxinA carries a strong recommendation for chronic migraine treatment. These decisions were based on a systematic review and meta-analysis that demonstrated the benefits of these treatments for most patients, with the positive effects outweighing potential risks.
The new guideline marks a significant move for healthcare professionals, offering them the latest evidence-based recommendations to help prevent and manage migraines. AbbVie’s commitment to supporting patients, as highlighted by these recommendations, aims to ease the burden of migraines and improve daily life for millions affected by the condition, ensuring patients have access to effective treatment options.
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MAVYRET FDA Regulatory Events
MAVYRET is a drug developed by AbbVie for the following indication: For the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MAVYRET
- Announced Date:
- June 11, 2025
- Indication:
- For the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
Announcement
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy.
AI Summary
AbbVie announced that the U.S. FDA has approved an important label expansion for its antiviral medicine MAVYRET® (glecaprevir/pibrentasvir). This approval extends the use of MAVYRET to treat both adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection, including those without cirrhosis or with compensated cirrhosis. It is the first and only oral direct acting antiviral (DAA) therapy approved for an eight‐week treatment course for acute HCV, boasting a 96% cure rate. This new label expansion enables healthcare providers to treat patients immediately after diagnosis, helping to reduce the risk of the infection progressing to severe liver complications. The expanded indication supports global public health goals and clinical guidelines aimed at eliminating hepatitis C by increasing timely testing and treatment options.
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EMRELIS FDA Regulatory Events
EMRELIS is a drug developed by AbbVie for the following indication: For locally advanced or metastatic, non-squamous non-small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EMRELIS
- Announced Date:
- May 14, 2025
- Indication:
- For locally advanced or metastatic, non-squamous non-small cell lung cancer
Announcement
AbbVie announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy.
AI Summary
AbbVie announced that its new drug, EMRELIS™ (telisotuzumab vedotin-tllv), has received accelerated approval by the U.S. Food and Drug Administration (FDA) for treating adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. This approval is for patients who have already received a prior systemic therapy and have limited treatment options. High c-Met protein overexpression means that 50% or more of the tumor cells show strong c-Met activity, which is linked to a poorer prognosis.
EMRELIS is the first and only treatment specifically approved for this patient group. The approval is based on data showing a promising overall response rate and duration of response from the Phase 2 LUMINOSITY study. This new targeted therapy offers hope to patients with a challenging form of lung cancer.
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Epcoritamab (DuoBody-CD3xCD20) FDA Regulatory Events
Epcoritamab (DuoBody-CD3xCD20) is a drug developed by AbbVie for the following indication: Follicular Lymphoma (FL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Epcoritamab (DuoBody-CD3xCD20)
- Announced Date:
- December 7, 2024
- Indication:
- Follicular Lymphoma (FL)
Announcement
AbbVie announced updated results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
AI Summary
AbbVie recently announced updated findings from the Phase 1b/2 EPCORE® NHL-2 trial, which looked at a new treatment option for adults with relapsed or refractory follicular lymphoma. The trial evaluated a fixed-duration dosing regimen of investigational epcoritamab—a CD3xCD20 bispecific T-cell-engaging antibody delivered subcutaneously—in combination with lenalidomide and rituximab (R2). Results showed impressive outcomes, with an overall response rate of 96% and a complete response rate of 87% among 111 patients over a median follow-up of more than two years. Additionally, 89% of patients who achieved a complete response maintained it at 18 months. These encouraging results support the further evaluation of this combination therapy in an ongoing Phase 3 trial and highlight its potential to offer a durable treatment alternative for patients with follicular lymphoma.
Read Announcement- Drug:
- Epcoritamab (DuoBody-CD3xCD20)
- Announced Date:
- June 2, 2024
- Indication:
- Follicular Lymphoma (FL)
Announcement
Genmab A/S announced new efficacy and safetydata from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with certain types of follicular lymphoma (FL).
AI Summary
Genmab A/S recently announced new efficacy and safety data from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody given by subcutaneous injection. In the EPCORE™ NHL-2 study, patients with previously untreated follicular lymphoma treated with epcoritamab in combination with rituximab-lenalidomide showed a 95% overall response rate and an 85% complete response rate. This data highlights the potential of a chemotherapy-free option for first-line treatment in this patient group.
In another trial, the EPCORE™ NHL-1 study, researchers focused on optimizing dosing by introducing mitigation strategies for cytokine release syndrome (CRS) and neurotoxicity. These strategies resulted in a significant reduction of CRS incidence, with no severe cases reported. Overall, these findings support further evaluation of epcoritamab as a promising treatment option for certain types of follicular lymphoma.
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JUVÉDERM VOLBELLA XC FDA Regulatory Events
JUVÉDERM VOLBELLA XC is a drug developed by AbbVie for the following indication: Undereye Hollows.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JUVÉDERM VOLBELLA XC
- Announced Date:
- October 2, 2024
- Indication:
- Undereye Hollows
Announcement
Allergan Aesthetics, an AbbVie company announces the national availability of JUVÉDERM® VOLUMA® XC for temple hollowing.
AI Summary
Allergan Aesthetics, an AbbVie company, announced the national availability of JUVÉDERM® VOLUMA® XC for treating moderate to severe temple hollowing in adults over 21. Following its FDA approval in March 2024, this is the first hyaluronic acid dermal filler specifically approved for the temple area. The treatment aims to provide a natural look and long-lasting improvement by reducing the hollow appearance in the temples, an important feature for achieving a balanced and youthful facial profile. In clinical studies, nearly 90% of patients were satisfied with the natural look and feel, while more than 85% noticed overall improvement, with results lasting up to 13 months. To ensure safety and efficacy, Allergan Aesthetics requires providers to complete comprehensive facial training on anatomy, patient selection, and safe injection techniques prior to offering the temple treatment.
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Teliso-V FDA Regulatory Events
Teliso-V is a drug developed by AbbVie for the following indication: In patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Teliso-V
- Announced Date:
- September 27, 2024
- Indication:
- In patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR)
Announcement
AbbVie announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
AI Summary
AbbVie announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of telisotuzumab vedotin (Teliso-V). This investigational antibody-drug conjugate is aimed at treating adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) that overexpresses the c-Met protein. Approximately 25% of patients in this NSCLC subgroup face a poor prognosis, and there are currently no approved anti-cancer therapies designed specifically for this population.
The BLA submission is supported by data from the ongoing Phase 2 LUMINOSITY trial and will undergo review under the FDA’s Real-Time Oncology Review program at the Oncology Center of Excellence. If approved, Teliso-V could become a first-in-class treatment option, offering new hope for patients with limited therapeutic choices.
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ABBV-400 FDA Regulatory Events
ABBV-400 is a drug developed by AbbVie for the following indication: For protein biomarkers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABBV-400
- Announced Date:
- September 9, 2024
- Indication:
- For protein biomarkers
Announcement
AbbVie announced that new data from its innovative antibody-drug conjugate (ADC) platform will be showcased at the upcoming European Society for Medical Oncology (ESMO) Congress 2024 (September 13-17, 2024). Presentations include data on mirvetuximab soravtansine (ELAHERE®) and c-Met targeting ADCs, telisotuzumab vedotin (Teliso-V) and telisotuzumab adizutecan (ABBV-400).
AI Summary
AbbVie announced that new data from its innovative antibody-drug conjugate (ADC) platform will be showcased at the European Society for Medical Oncology (ESMO) Congress 2024, held September 13–17. The presentations will feature results on mirvetuximab soravtansine (ELAHERE®) together with data on c-Met targeting ADCs, including telisotuzumab vedotin (Teliso-V) and telisotuzumab adizutecan (ABBV-400). These ADCs are engineered to target biomarkers like folate receptor-alpha and c-Met, which are often overexpressed in various cancer types and linked to poor prognoses. The showcased data will illustrate the potential of these therapies in treating conditions like platinum-sensitive ovarian cancer and advanced non-small cell lung cancer, among others. AbbVie’s commitment to advancing innovative cancer treatments is highlighted by these studies, which offer promising outcomes in targeted therapy approaches for patients with unmet medical needs.
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Cariprazine (VRAYLAR) FDA Regulatory Events
Cariprazine (VRAYLAR) is a drug developed by AbbVie for the following indication: Major Depressive Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cariprazine (VRAYLAR)
- Announced Date:
- September 4, 2024
- Indication:
- Major Depressive Disorder
Announcement
AbbVie announced that Canada's Drug Agency (CDA, formerly CADTH) has recommended that VRAYLAR be reimbursed with conditions, for the treatment of schizophrenia in adults.
AI Summary
AbbVie announced that Canada’s Drug Agency (CDA, formerly CADTH) has recommended that VRAYLAR be reimbursed—with conditions—for treating schizophrenia in adults. This decision, which supersedes a previous CADTH recommendation, highlights the aim to improve access to new treatment options for patients facing severe mental illness. Mental health experts and organizations have welcomed the news, noting that many patients, particularly those without private insurance, rely on public drug plans for necessary treatment.
VRAYLAR, an atypical antipsychotic, has been making steady progress through Canadian regulatory channels since receiving its Notice of Compliance in April 2022. The latest CDA recommendation underscores the commitment of AbbVie, along with government and clinical partners, to address the significant unmet needs of schizophrenia patients by providing access to innovative medications.
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TEPKINLY FDA Regulatory Events
TEPKINLY is a drug developed by AbbVie for the following indication: For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TEPKINLY
- Announced Date:
- June 28, 2024
- Indication:
- For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Announcement
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorization of epcoritamab (TEPKINLY®), the first and only T-cell engaging bispecific antibody administered subcutaneously (under the skin), as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies.
AI Summary
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the conditional marketing authorization of epcoritamab (TEPKINLY®). This approval is based on data from the Phase 1/2 EPCORE® NHL-1 study and is significant because epcoritamab is the first and only T-cell engaging bispecific antibody administered subcutaneously as a monotherapy for treating adults with relapsed or refractory follicular lymphoma (FL) after at least two previous therapies. The CHMP decision addresses an unmet need for FL patients in the European Union who often face disease recurrence and diminishing responses with each treatment line. AbbVie and Genmab are co-developing the drug, and the European Commission’s final decision on this indication is expected later this year.
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ABBV-951 (Foslevodopa/Foscarbidopa) FDA Regulatory Events
ABBV-951 (Foslevodopa/Foscarbidopa) is a drug developed by AbbVie for the following indication: Advanced Parkinson's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABBV-951 (Foslevodopa/Foscarbidopa)
- Announced Date:
- June 25, 2024
- Indication:
- Advanced Parkinson's Disease
Announcement
AbbVie announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
AI Summary
AbbVie announced that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application for ABBV-951 (foscarbidopa/foslevodopa), a treatment for motor fluctuations in adults with advanced Parkinson’s disease. The FDA’s letter was based on observations made during an inspection of a third-party manufacturing facility that did not produce ABBV-951 or any other AbbVie product.
The CRL did not raise any concerns about the safety, effectiveness, or labeling of ABBV-951. The FDA is not asking for further trials related to the drug or its delivery device. AbbVie is actively working with the FDA to resolve the issues and bring this new therapy to patients as soon as possible, emphasizing the significant unmet need for better treatment options for advanced Parkinson’s disease.
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ELAHERE (mirvetuximab soravtansine-gynx) FDA Regulatory Events
ELAHERE (mirvetuximab soravtansine-gynx) is a drug developed by AbbVie for the following indication: ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ELAHERE (mirvetuximab soravtansine-gynx)
- Announced Date:
- June 6, 2024
- Indication:
- ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells
Announcement
AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC).
AI Summary
AbbVie announced positive topline results from its Phase 2 PICCOLO trial, which studied the investigational mirvetuximab soravtansine (ELAHERE®) in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer. The trial met its primary endpoint with an objective response rate (ORR) of 51.9%, suggesting a strong treatment effect in these patients who have limited options. Additionally, the study reported a median duration of response of 8.25 months, indicating that the benefits of the treatment may last for a significant period. The safety profile observed was consistent with previous studies, with no new safety concerns, which supports the potential for mirvetuximab soravtansine as an effective option for women facing multiple lines of therapy. Full data from this trial will be shared at an upcoming medical meeting, adding further insight into its clinical promise.
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