FDA Grants Priority Review to Takeda's Zasocitinib for Moderate-to-Severe Plaque Psoriasis

The U.S. Food and Drug Administration (FDA) has accepted Takeda's New Drug Application (NDA) for zasocitinib (TAK-279) under Priority Review for the treatment of adults with moderate-to-severe plaque psoriasis. Zasocitinib is an investigational, next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor. The acceptance is based on pivotal Phase 3 data demonstrating rapid, durable, and consistent skin clearance. The European Medicines Agency (EMA) has also accepted Takeda's marketing authorization application for the drug.