Takeda psoriasis drug gets FDA priority review
- Takeda (NYSE:TAK) received FDA Priority Review for its zasocitinib NDA in moderate-to-severe plaque psoriasis.
- About 70% of patients achieved clear or almost clear skin at week 16 in supporting Phase 3 studies.
- Takeda is also pursuing European approval and plans additional regulatory submissions globally.
Takeda (NYSE:TAK) said the U.S. FDA accepted its New Drug Application for zasocitinib under Priority Review for adults with moderate-to-severe plaque psoriasis.
The application is supported by Phase 3 LATITUDE PsO studies involving a development program of nearly 3,000 patients, with the pivotal 3001 and 3002 trials meeting all primary and ranked secondary endpoints.
About 70% of patients achieved clear or almost clear skin at week 16, while Takeda reported skin clearance from week 4 through weeks 24 and 52 and no new safety signals.
Takeda said the European Medicines Agency has also accepted its marketing authorization application for zasocitinib, beginning a separate European review for moderate-to-severe plaque psoriasis.
The company plans additional global regulatory applications for zasocitinib and said the NDA filing has no significant effect on its consolidated financial forecast for the fiscal year ending March 31, 2027.
