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FDA accepts Takeda's Priority Review for zasocitinib to treat moderate-to-severe plaque psoriasis
TAKTakeda Pharmaceutical Co Ltd
Takeda Pharmaceutical announced that the U.S. FDA accepted its New Drug Application for zasocitinib (TAK-279) under Priority Review for the treatment of moderate-to-severe plaque psoriasis. The submission is supported by pivotal Phase 3 LATITUDE PsO studies involving nearly 3,000 patients, which demonstrated rapid and durable skin clearance with approximately 70% of patients achieving clear or almost clear skin at week 16. The European Medicines Agency also accepted the marketing authorization application. The Prescription Drug User Fee Act target action date is in the first quarter of calendar year 2027. Takeda stated the filing has no significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027. Takeda is a global biopharmaceutical company focused on discovering and delivering treatments in areas such as oncology, neuroscience, vaccines, and rare diseases.