U.S. FDA Accepts Takeda's Zasocitinib for Priority Review in Moderate-to-Severe Plaque Psoriasis; EMA Also Initiates Review

The U.S. Food and Drug Administration (FDA) has accepted Takeda's New Drug Application (NDA) for zasocitinib (TAK-279) under Priority Review for adults with moderate-to-severe plaque psoriasis. Concurrently, the European Medicines Agency (EMA) has initiated its review process for the same treatment. Zasocitinib is an investigational, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, with Phase 3 data demonstrating rapid and durable skin clearance.