This section highlights FDA-related milestones and regulatory updates for drugs developed by Takeda Pharmaceutical (TAK).
Over the past two years, Takeda Pharmaceutical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TAK-881, TAK-279, TAK-861, vedolizumab, TAK-079, TAK-003, and HYQVIA. 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.
TAK-881 FDA Regulatory Events
TAK-881 is a drug developed by Takeda Pharmaceutical for the following indication: in Primary Immunodeficiency Disease (PID).
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:
- TAK-881
- Announced Date:
- May 4, 2026
- Indication:
- in Primary Immunodeficiency Disease (PID)
Announcement
Takeda announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase].
Read Announcement
TAK-279 FDA Regulatory Events
TAK-279 is a drug developed by Takeda Pharmaceutical for the following indication: For the Treatment of Active Psoriatic Arthritis.
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:
- TAK-279
- Announced Date:
- March 31, 2026
- Indication:
- For the Treatment of Active Psoriatic Arthritis
Announcement
Takeda Canada Inc. is pleased to announce new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).
AI Summary
Takeda Canada Inc. announced new data from two pivotal Phase 3 studies (LATITUDE PsO 3001 and 3002) of zasocitinib (TAK‑279), a next‑generation, highly selective oral TYK2 inhibitor for adults with moderate‑to‑severe plaque psoriasis. In both trials, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of success.
Zasocitinib also showed statistically significant improvements in complete skin clearance, an increasingly important treatment goal for people with plaque psoriasis. The drug was generally well tolerated, and the safety and tolerability seen in these Phase 3 studies remained consistent with earlier trials.
Takeda said it is on track to submit a New Drug Application to the United States Food and Drug Administration and similar filings to Health Canada and other regulators beginning in fiscal year 2026. The company noted these results do not materially affect its full‑year consolidated forecast.
Read Announcement- Drug:
- TAK-279
- Announced Date:
- December 18, 2025
- Indication:
- For the Treatment of Active Psoriatic Arthritis
Announcement
Takeda Pharmaceutical Co., Ltd announced positive topline results for the two pivotal Phase 3studies of zasocitinib (TAK-279) for moderate-to-severe plaque psoriasis (PsO).
AI Summary
Takeda announced positive topline results from two pivotal Phase 3 studies of zasocitinib (TAK-279), a once-daily oral TYK2 inhibitor for adults with moderate-to-severe plaque psoriasis. Both randomized, double-blind, placebo- and active-controlled trials met the co-primary endpoints — static Physician Global Assessment (sPGA) 0/1 and PASI 75 — at week 16, showing superiority versus placebo. A significantly greater PASI 75 response was seen as early as week 4 and continued to increase through week 24.
More than half of patients on zasocitinib achieved PASI 90 (clear or almost clear skin) by week 16, and about 30% reached PASI 100 (completely clear skin). All 44 ranked secondary endpoints were met, including comparisons versus apremilast. Zasocitinib was generally well tolerated; the most common adverse events were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.
The studies enrolled participants across 21 countries. Takeda plans to present the data at medical meetings and aims to submit regulatory applications beginning in fiscal 2026.
Read Announcement
TAK-861 FDA Regulatory Timeline and Events
TAK-861 is a drug developed by Takeda Pharmaceutical for the following indication: In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
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:
- TAK-861
- Announced Date:
- February 10, 2026
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1).
AI Summary
Takeda announced that the U.S. Food and Drug Administration accepted its New Drug Application for oveporexton (TAK-861) and granted Priority Review for the drug as a treatment for narcolepsy type 1 (NT1). Acceptance of the NDA formally places the application into the FDA’s review process, and Priority Review means the agency will aim to reach a decision on a shorter timetable — typically about six months instead of the standard review period.
Takeda said the NDA filing does not have a significant impact on its full-year consolidated forecast for the fiscal year ending March 31, 2026. The company will now work with the FDA through the Priority Review process while stakeholders await the agency’s decision and any further regulatory communications or requirements.Read Announcement
- Drug:
- TAK-861
- Announced Date:
- September 8, 2025
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore beginning at 3:15 p.m. SGT today.
AI Summary
Takeda will present data from two global Phase 3 double‐blind, placebo‐controlled studies of oveporexton (TAK-861), a potential first-in-class oral orexin receptor 2 (OX2R) agonist for narcolepsy type 1 (NT1), during multiple oral sessions at World Sleep 2025 in Singapore starting at 3:15 p.m. SGT today.
The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) trials both met all primary and secondary endpoints, showing statistically significant improvements (p < 0.001) in excessive daytime sleepiness, cataplexy, symptom severity and quality of life at week 12 with twice-daily 1 mg and 2 mg doses versus placebo.
Oveporexton was generally well tolerated, with no serious treatment-related adverse events reported. The most common side effects were mild to moderate insomnia, urinary urgency and increased frequency, consistent with prior studies.
These data support oveporexton’s potential to address the underlying orexin deficiency in NT1 and may herald a new era of care by fully targeting the root cause of narcolepsy type 1.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- July 14, 2025
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1).
AI Summary
Takeda announced that both Phase 3 trials of oveporexton (TAK-861), a potential first-in-class oral orexin receptor 2 agonist, met all primary and secondary endpoints in patients with narcolepsy type 1 (NT1). Oveporexton is designed to overcome the underlying orexin deficiency responsible for NT1 by stimulating wakefulness and reducing related symptoms. The randomized, double-blind, placebo-controlled studies showed statistically significant improvements in wakefulness, daytime alertness, and overall symptom control compared to placebo.
These promising results build on earlier Phase 2b findings and mark a major step toward transforming the care of NT1 patients. With a favorable safety profile and manageable side effects, oveporexton’s success supports Takeda’s plans for rapid regulatory submissions and launch. The company is focused on bringing this innovative treatment to people living with NT1 as quickly as possible while improving their quality of life.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- May 14, 2025
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1).
AI Summary
Takeda announced that the New England Journal of Medicine has published data from its Phase 2b clinical trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). The study examined the effectiveness of this investigational oral orexin receptor 2 agonist, which is designed to restore orexin signaling, addressing the root cause of NT1. Results showed statistically significant improvements in both primary and secondary endpoints compared to placebo. Most subjects achieved near normal levels of wakefulness, experienced fewer cataplexy events, and noticed meaningful improvements in overall quality of life. Additionally, oveporexton was generally found to be safe and well tolerated with mostly mild to moderate side effects. These encouraging outcomes support further development of this treatment approach, and Takeda anticipates a Phase 3 trial readout in 2025.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- September 19, 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain.
AI Summary
Takeda will present additional insights on its experimental drug TAK-861 at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, held in Seville, Spain from September 24-27, 2024. The company will showcase data from the Phase 2b trials (TAK-861-2001 and TAK-861-2002) along with results from the long-term extension study (TAK-861-2003). These studies focus on patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2), and aim to demonstrate how TAK-861 may improve daily functioning by addressing issues related to sleep quality and cognition. This presentation will add valuable information on the drug’s performance, supporting its potential to offer a new treatment approach for narcolepsy by targeting the underlying orexin deficiency observed in NT1 patients.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- June 3, 2024
- Target Action Date:
- H1 2024
- Estimated Target Date Range:
- January 1, 2024 - June 30, 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that Phase 3 Trials of TAK-861 to be Initiated in 1H FY2024
AI Summary
Takeda announced it will begin global Phase 3 trials of TAK-861 in narcolepsy type 1 (NT1) during the first half of fiscal year 2024. This announcement follows positive results from its Phase 2b trial, where TAK-861, the first oral orexin receptor 2 agonist developed to tackle the underlying orexin deficiency in NT1, showed statistically significant and clinically meaningful improvements. The trial demonstrated sustained benefits over eight weeks, with notable enhancements in sleep latency and other key measures of sleepiness and cataplexy. Additionally, TAK-861 was generally safe and well tolerated, with only mild to moderate adverse events reported. These promising findings lay the groundwork for the upcoming Phase 3 studies, which aim to confirm TAK-861’s potential as a transformative treatment option for patients suffering from NT1.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- June 3, 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda will present today positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society.
AI Summary
Takeda announced that it will present positive results from its Phase 2b trial of TAK-861 for narcolepsy type 1 (NT1) at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. The trial demonstrated statistically significant and clinically meaningful improvements on the primary endpoint—the Maintenance of Wakefulness Test—as well as key secondary endpoints, including subjective sleepiness and cataplexy frequency, with benefits sustained over an 8‑week period.
TAK-861, an investigational oral orexin receptor 2 agonist, is designed to address the underlying cause of NT1 by targeting the orexin deficiency. The study also showed that TAK-861 was generally safe and well tolerated, reinforcing its potential as a transformative treatment option. Based on these promising results, Takeda plans to initiate global Phase 3 trials in the first half of fiscal year 2024.
Read Announcement
Vedolizumab FDA Regulatory Events
Vedolizumab is a drug developed by Takeda Pharmaceutical for the following indication: approved in intravenous (IV) and subcutaneous (SC) formulations.
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:
- vedolizumab
- Announced Date:
- February 5, 2026
- Indication:
- approved in intravenous (IV) and subcutaneous (SC) formulations
Announcement
Alvotech announced today positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio® (vedolizumab).
AI Summary
Alvotech announced positive top-line results from a pharmacokinetic (PK) study of AVT80, its biosimilar candidate to Entyvio® (vedolizumab). The study compared AVT80 and Entyvio in healthy adult participants and evaluated PK, safety, tolerability and immunogenicity. According to the company, the trial met all primary endpoints, indicating that AVT80 behaved similarly to Entyvio in the measures the study set out to compare.
Entyvio is used to treat adults with moderate to severe ulcerative colitis and Crohn’s disease, conditions that cause inflammation in the digestive tract. The strong top-line PK results are an important step for AVT80 as Alvotech continues its development program for a potential biosimilar option to vedolizumab.Read Announcement
TAK-079 FDA Regulatory Events
TAK-079 is a drug developed by Takeda Pharmaceutical for the following indication: For Primary Immune Thrombocytopenia.
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:
- TAK-079
- Announced Date:
- November 7, 2025
- Indication:
- For Primary Immune Thrombocytopenia
Announcement
Takeda announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease-modifying potential, in primary immunoglobulin A (IgA) nephropathy. Data from the study showed that kidney function (eGFR) remained stable in patients with IgA nephropathy through Week 96 – up to 18 months after the last mezagitamab dose.1
AI Summary
Takeda reported interim results from a Phase 1b, open-label proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease‑modifying potential, in primary IgA nephropathy. Kidney function (eGFR) remained stable through Week 96 — up to 18 months after the last mezagitamab dose. Rapid reductions in proteinuria and in the abnormal Gd‑IgA1 protein were seen early and were sustained through Week 96. Hematuria (blood in the urine) resolved in 60% of patients by Week 96.
Seventeen patients received mezagitamab and 13 entered long‑term follow up. At Week 96 the mean change in eGFR was +2.5 mL/min/1.73 m2 (95% CI: −1.8, +7.6; n=12) and mean proteinuria fell 55.2% (95% CI: 30.2, 72.6; n=13). Gd‑IgA1 fell about 50.1% and IgG recovered toward baseline. The drug was generally well tolerated with no serious adverse events, no opportunistic infections and no serious hypersensitivity or injection‑related reactions reported through Week 96. Takeda has initiated pivotal Phase 3 trials with enrollment ongoing.
Read Announcement
TAK-003 FDA Regulatory Events
TAK-003 is a drug developed by Takeda Pharmaceutical for the following indication: Dengue.
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:
- TAK-003
- Announced Date:
- November 3, 2025
- Indication:
- Dengue
Announcement
Takeda announced the completion of the 7-year pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial evaluating its dengue vaccine, QDENGA®▼(Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
AI Summary
Takeda announced the completion of the seven-year pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial for its live-attenuated dengue vaccine, QDENGA® (TAK-003). The double-blind, randomized trial enrolled more than 20,000 healthy children and adolescents (4–16 years) in eight dengue-endemic countries. Participants received two doses at months 0 and 3, which delivered 61.2% efficacy against virologically confirmed dengue over 4.5 years. A booster at year 4.5 increased efficacy to 74.3% after two additional years. Protection against dengue-related hospitalizations was 84.1% without the booster and rose to 90.6% after. QDENGA® maintained consistent efficacy across all four dengue serotypes through seven years, with no new safety signals. These findings reinforce its favorable long-term safety and support a simple two-dose schedule that can improve adherence and help expand global access to dengue prevention.
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HYQVIA FDA Regulatory Timeline and Events
HYQVIA is a drug developed by Takeda Pharmaceutical for the following indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
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:
- HYQVIA
- Announced Date:
- July 21, 2025
- Indication:
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Announcement
Takeda announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHubTM and HyHubTM Duo, devices for patients 17 years of age and older that allow HYQVIA® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.2
AI Summary
Takeda announced that the U.S. Food and Drug Administration has granted 510(k) clearance for HyHub™ and HyHub™ Duo, two new devices for patients 17 years and older. These devices let users transfer HYQVIA® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] from vials without a needle, whether at home or in a clinic.
Built as simple docking stations for the dual vial units of HYQVIA, HyHub and HyHub Duo can cut the steps needed to prepare an infusion by up to half (for four vials) or one third (for two vials). They also reduce extra supplies and include a carrier bag so patients can move from room to room during infusion.
Developed with input from patients and caregivers, these are Takeda’s first devices tailored to a plasma-derived therapy. HyHub and HyHub Duo will be provided at no extra cost and are expected to launch in the United States in the second half of fiscal year 2025, with a CE Mark application submitted for the European Union.
Read Announcement- Drug:
- HYQVIA
- Announced Date:
- December 27, 2024
- Indication:
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Announcement
Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)2.
AI Summary
Takeda announced that Japan’s Ministry of Health, Labour and Welfare has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for treating patients with agammaglobulinemia or hypogammaglobulinemia. These conditions, marked by very low or absent levels of antibodies, raise the risk of serious recurring infections due to primary or secondary immunodeficiencies.
HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy available in Japan. The product combines immunoglobulin and recombinant human hyaluronidase, which helps increase the dispersion and absorption of the infused fluid, allowing for larger volumes per dose. This results in a more flexible treatment schedule with less frequent dosing—every three or four weeks—in contrast to traditional subcutaneous therapies that require weekly or bi-weekly infusions.
Read Announcement- Drug:
- HYQVIA
- Announced Date:
- June 18, 2024
- Indication:
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Announcement
Takeda announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
Takeda announced new data from its Phase 3 ADVANCE-CIDP 3 clinical trial, a long‐term extension study that evaluated HYQVIA® in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The study, which is the longest extension trial in CIDP to date, enrolled 85 patients and showed that HYQVIA maintained a stable disease course with a low relapse rate. Results confirmed that HYQVIA has a favorable long-term safety and tolerability profile. Patients received a median treatment duration of 33 months, and most doses were administered every four weeks, offering the convenience of monthly treatment. This data supports HYQVIA’s effectiveness as a maintenance therapy for CIDP, potentially allowing self-administration at home after proper training. The findings will be further discussed at the Peripheral Nerve Society Annual Meeting in June 2024.
Read Announcement
Brentuximab vedotin FDA Regulatory Events
Brentuximab vedotin is a drug developed by Takeda Pharmaceutical for the following indication: In adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
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:
- brentuximab vedotin
- Announced Date:
- June 3, 2025
- Indication:
- In adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
Announcement
Takeda announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
AI Summary
Takeda announced that the European Commission (EC) has approved ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (ECADD) for adult patients with newly diagnosed Stage IIb with risk factors, III, or IV Hodgkin lymphoma. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on results from the Phase 3 HD21 trial.
In the trial, the ADCETRIS-based regimen, known as BrECADD, demonstrated a superior safety profile compared to the standard eBEACOPP regimen while maintaining effective progression-free survival. The new combination offers physicians greater treatment flexibility and may improve long-term outcomes. This approval marks a significant advancement in expanding treatment options for frontline Hodgkin lymphoma care in the European Union.
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CABOMETYX (cabozantinib) + OPDIVO (nivolumab) FDA Regulatory Events
CABOMETYX (cabozantinib) + OPDIVO (nivolumab) is a drug developed by Takeda Pharmaceutical for the following indication: Unresectable or Metastatic Renal Cell Carcinoma.
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:
- CABOMETYX (cabozantinib) + OPDIVO (nivolumab)
- Announced Date:
- February 15, 2025
- Indication:
- Unresectable or Metastatic Renal Cell Carcinoma
Announcement
Exelixis, Inc announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC).
AI Summary
Exelixis, Inc. announced the final results from its phase 3 CheckMate‑9ER pivotal trial comparing CABOMETYX® (cabozantinib) combined with Opdivo® (nivolumab) to sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). After more than five years of follow‐up, the combination therapy demonstrated a lasting survival benefit over sunitinib. The trial showed that patients receiving CABOMETYX plus Opdivo experienced improved progression‐free survival, with a hazard ratio of 0.58, and overall survival, with a hazard ratio of 0.79. Additionally, subgroup analyses revealed that the long-term efficacy was maintained regardless of metastases location, including liver, bone, and lung. These positive findings support the use of the CABOMETYX and Opdivo regimen as a valuable first-line treatment option, offering durable clinical benefits for patients with advanced RCC.
Read Announcement
FRUZAQLA (fruquintinib) FDA Regulatory Timeline and Events
FRUZAQLA (fruquintinib) is a drug developed by Takeda Pharmaceutical for the following indication: For Metastatic Colorectal 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:
- FRUZAQLA (fruquintinib)
- Announced Date:
- January 21, 2025
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda Canada Inc is pleased to announce that Health Canada has provided market authorization for FRUZAQLA™ (fruquintinib capsules), indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.1
AI Summary
Takeda Canada Inc. announced that Health Canada has authorized the market for FRUZAQLA™ (fruquintinib capsules). This new treatment is designed for adult patients with metastatic colorectal cancer (mCRC) who have already received, or are not eligible for, standard therapies. These therapies include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, along with an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
The approval is backed by positive reimbursement recommendations from Canada’s Drug Agency (CDA-AMC) and the Institut national d’excellence en santé et services sociaux (INESSS). FRUZAQLA works by inhibiting VEGFR-1, -2, and -3, which helps prevent tumors from making new blood vessels, thereby slowing down cancer progression. This new option provides hope and an additional treatment opportunity for Canadian patients battling mCRC.
Read Announcement- Drug:
- FRUZAQLA (fruquintinib)
- Announced Date:
- September 24, 2024
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.
AI Summary
Takeda announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (fruquintinib). This selective oral inhibitor targets VEGFR‐1, ‐2, and ‐3, and is designed for advanced or recurrent colorectal cancer that is neither curable nor resectable and has progressed after chemotherapy. The approval is based on positive data from the global Phase 3 FRESCO-2 trial, which showed significant improvements in overall survival and progression-free survival compared to placebo. The trial enrolled patients from multiple regions, including Japan, and demonstrated a manageable safety profile along with consistent efficacy regardless of prior treatment types. With this approval, Takeda solidifies its commitment to introducing innovative cancer therapies, offering renewed hope and improved treatment options for patients facing limited alternatives in advanced colorectal cancer.
Read Announcement - Drug:
- FRUZAQLA (fruquintinib)
- Announced Date:
- June 21, 2024
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
AI Summary
Takeda recently announced that the European Commission approved FRUZAQLA (fruquintinib) as a monotherapy for adult patients with metastatic colorectal cancer (mCRC) who have already received standard treatments. These treatments include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, as well as anti-VEGF and anti-EGFR agents. The approval is specifically for patients whose disease has progressed on or who are unable to tolerate further treatment with trifluridine-tipiracil or regorafenib.
This decision, following the Committee for Medicinal Products for Human Use’s positive opinion, is based on encouraging results from the global Phase 3 FRESCO-2 trial. The study showed that FRUZAQLA improved key efficacy endpoints while maintaining a manageable safety profile. The approval marks the first novel targeted treatment option for mCRC in the European Union in over a decade, offering patients a chemotherapy-free, oral treatment that is effective regardless of biomarker status.
Read Announcement
ADZYNMA® FDA Regulatory Events
ADZYNMA® is a drug developed by Takeda Pharmaceutical for the following indication: For Congenital Thrombotic Thrombocytopenic Purpura (cTTP).
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:
- ADZYNMA®
- Announced Date:
- August 7, 2024
- Indication:
- For Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
Announcement
Takeda announced that the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP).3
AI Summary
Takeda announced that the European Commission has approved ADZYNMA® (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP). This approval marks a significant milestone as ADZYNMA becomes the first and only enzyme replacement therapy in the European Union specifically designed for cTTP. The decision was based on comprehensive evidence from the first randomized, controlled Phase 3 trial in cTTP, which showed that patients receiving ADZYNMA experienced no acute TTP events during prophylactic treatment, in contrast to those on plasma-based therapies. The trial results also demonstrated that ADZYNMA has a favorable safety profile with common reactions including headache and nausea. This development provides a new treatment option for patients facing a life-threatening disorder with limited alternatives and underscores Takeda's commitment to advancing care in rare blood disorders.
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LIVTENCITY® (maribavir) FDA Regulatory Events
LIVTENCITY® (maribavir) is a drug developed by Takeda Pharmaceutical for the following indication: For Post-Transplant Cytomegalovirus (CMV) Infection/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:
- LIVTENCITY® (maribavir)
- Announced Date:
- June 24, 2024
- Indication:
- For Post-Transplant Cytomegalovirus (CMV) Infection/Disease
Announcement
Takeda announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW)for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.
AI Summary
Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved LIVTENCITY® (maribavir) for treating post-transplant cytomegalovirus (CMV) infections or diseases that do not respond to existing anti-CMV therapies. This approval marks LIVTENCITY as the first and only treatment in Japan that specifically targets and inhibits the UL97 protein kinase, a key enzyme for CMV replication. The drug offers a new therapeutic option for transplant patients facing challenging cases of CMV, which can lead to serious complications, including organ rejection and graft failure. Based on promising clinical data, including results from Phase 3 trials, Takeda is hopeful that LIVTENCITY will significantly improve treatment outcomes for patients who have not benefited from other available therapies, thereby transforming the management of post-transplant CMV infections in Japan.
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TAK-935 FDA Regulatory Events
TAK-935 is a drug developed by Takeda Pharmaceutical for the following indication: In Patients with Dravet Syndrome and Lennox-Gastaut Syndrome.
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:
- TAK-935
- Announced Date:
- June 17, 2024
- Indication:
- In Patients with Dravet Syndrome and Lennox-Gastaut Syndrome
Announcement
Takeda announced topline data from its SKYLINE and SKYWAY studies.
AI Summary
Takeda announced topline data from its Phase 3 SKYLINE and SKYWAY studies. In the SKYLINE study for patients with Dravet syndrome, soticlestat used as an add-on treatment narrowly missed the primary endpoint of reducing convulsive seizure frequency, with a p-value of 0.06. However, the study showed clinically meaningful benefits in multiple key secondary endpoints such as responder rates, caregiver and clinician global impressions, and seizure intensity and duration scores over 16 weeks. The SKYWAY study, which focused on Lennox-Gastaut syndrome, also did not meet its primary endpoint of reducing major motor drop seizures. Despite these results, soticlestat demonstrated a consistent and favorable safety and tolerability profile in both studies, and Takeda plans to discuss the totality of this data with regulatory authorities to determine the next steps.
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