Takeda: FDA accepts NDA for zasocitinib (TAK-279) under Priority Review
- FDA accepted the New Drug Application for zasocitinib (TAK-279) under Priority Review.
- PDUFA target action date is in the first quarter of calendar year 2027.
- NDA is supported by pivotal global Phase 3 LATITUDE PsO 3001 and 3002 plus supportive open-label 3003, covering nearly 3,000 patients.
- About 70% of patients achieved sPGA 0/1 at week 16; clearance seen as early as week 4 and durable through week 52, including in scalp, nails, palms and soles.
Regulatory status
The U.S. Food and Drug Administration accepted Takeda’s New Drug Application for zasocitinib (TAK-279) under Priority Review for treatment of adults with moderate-to-severe plaque psoriasis. The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027. The European Medicines Agency has also accepted Takeda’s marketing authorization application, and Takeda plans further global regulatory submissions.
Clinical evidence
Zasocitinib is an investigational, next-generation, oral TYK2 inhibitor administered once daily. The NDA is supported by pivotal global Phase 3 LATITUDE PsO 3001 and 3002 studies, which met all primary and ranked secondary endpoints, and by supportive data from the open-label LATITUDE PsO 3003 long-term study. Across nearly 3,000 patients, about 70% achieved clear or almost clear skin (sPGA 0/1) at week 16; skin clearance was observed as early as week 4 and increased through week 24 and 52. High levels of clearance were reported in hard-to-treat, high-impact sites including scalp, nails, palms and soles.
Safety and next steps
Zasocitinib was generally well tolerated in the reported studies and no new safety signals were identified. Takeda said the NDA filing has no significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027, and will continue regulatory engagements to bring the treatment to patients worldwide.
Source: Takeda