Takeda's Zasocitinib Gets FDA Priority Review for Plaque Psoriasis Treatment

Takeda's Zasocitinib NDA has been accepted by the FDA under priority review for moderate-to-severe plaque psoriasis. The Prescription Drug User Fee Act target action date is set for Q1 2027. The investigational oral tyrosine kinase 2 inhibitor maintains 24-hour inhibition of IL-23 and other disease-driving immune pathways. The NDA acceptance was supported by Phase 3 LATITUDE PsO 3001 and 3002 studies, which met co-primary and 44 secondary endpoints.