FDA Accepts Takeda's New Drug Application for Zasocitinib in Moderate-to-Severe Plaque Psoriasis Under Priority Review

The U.S. Food and Drug Administration (FDA) has accepted Takeda's New Drug Application (NDA) for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis, granting it Priority Review. Zasocitinib is an investigational, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable, and consistent skin clearance in Phase 3 studies, including in high-impact sites. The Prescription Drug User Fee Act (PDUFA) target action date is set for the first quarter of calendar year 2027.