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
ABBV-400, ABBV-951, ABBV-RGX-314, Atogepant, BOTOX, Cariprazine, and ELAHERE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ABBV-400 - FDA Regulatory Timeline and 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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ABBV-951 (Foslevodopa/Foscarbidopa) - FDA Regulatory Timeline and 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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ABBV-RGX-314 - FDA Regulatory Timeline and 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:
- 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.
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Atogepant - FDA Regulatory Timeline and 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.
Read Announcement- Drug:
- Atogepant
- Announced Date:
- April 12, 2024
- Indication:
- Episodic Migraine
Announcement
AbbVie announced an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.
AI Summary
AbbVie announced the interim results from a Phase 3, open-label, 156‐week extension study on the long-term use of atogepant 60 mg for preventing chronic or episodic migraine. The study supports that atogepant remains safe and well tolerated over an extended period, with no new safety issues identified. Notably, around 70% of participants experienced a reduction of at least 50% in their monthly migraine days during Weeks 13–16—a benefit that continued consistently through 48 weeks of treatment. These findings also include marked improvements in monthly headache days and a decrease in the days participants used acute medications. This analysis strengthens evidence for atogepant’s potential as a long-term preventive treatment option for those burdened by migraine, offering sustained relief and improved quality of life for patients across different migraine types.
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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:
- 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.
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Cariprazine (VRAYLAR) - FDA Regulatory Timeline and 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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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:
- 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.
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ELAHERE (mirvetuximab soravtansine-gynx) - FDA Regulatory Timeline and 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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EMRELIS - FDA Regulatory Timeline and 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 Timeline and 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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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:
- 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.
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JUVÉDERM VOLBELLA XC - FDA Regulatory Timeline and 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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MAVYRET - FDA Regulatory Timeline and 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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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 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- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- April 25, 2024
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study that evaluated the efficacy and safety of upadacitinib (RINVOQ®, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (DUPIXENT®, per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable.
AI Summary
AbbVie recently reported positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded Phase 3b/4 study comparing upadacitinib (RINVOQ®) and dupilumab (DUPIXENT®) in treating moderate-to-severe atopic dermatitis. The study involved adults and adolescents (aged 12 and older) who had an inadequate response to systemic therapies or for whom these treatments were not advisable. At Week 16, the primary endpoint—simultaneously achieving near complete skin clearance (EASI 90) and little to no itch (WP-NRS 0/1)—was met by a significantly higher percentage of patients treated with upadacitinib (19.9%) compared to those on dupilumab (8.9%). Secondary endpoints also favored upadacitinib, showcasing a quick onset of action. Additionally, the safety profile of upadacitinib during the study was consistent with previous research, with no new safety signals identified.
Read Announcement- Drug:
- RINVOQ (upadacitinib)
- Announced Date:
- April 18, 2024
- Indication:
- Moderate to Severe Atopic Dermatitis
Announcement
AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA).
AI Summary
AbbVie announced positive top-line results from the Phase 3 SELECT-GCA study, showing that upadacitinib (RINVOQ® 15 mg once daily) combined with a 26‑week steroid taper regimen achieved sustained remission in adults with giant cell arteritis (GCA). In the study, 46% of patients given upadacitinib reached sustained remission from week 12 through week 52, compared with 29% of patients who received a placebo plus a 52‑week steroid taper. The study was multicenter, randomized, and double‑blind, making the results robust and reliable.
Importantly, the safety profile in patients with GCA was similar to that seen in previously approved indications, with no new safety issues detected. These findings highlight upadacitinib’s potential as a new oral treatment option for GCA, an autoimmune disease that has limited treatment choices and can lead to serious symptoms such as vision loss and severe headaches.
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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:
- 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.
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Tavapadon (TEMPO-3) - FDA Regulatory Timeline and Events
Tavapadon (TEMPO-3) 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 (TEMPO-3)
- 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 (TEMPO-3)
- 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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Teliso-V - FDA Regulatory Timeline and 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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TEPKINLY - FDA Regulatory Timeline and 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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TrenibotE - FDA Regulatory Timeline and 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 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.
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venetoclax - FDA Regulatory Timeline and 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:
- 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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