US FDA approved BMS Sotyktu (deucravacitinib) for moderate to severe plaque psoriasis.
The US FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for treating patients with moderate-to-severe plaque psoriasis.
In Phase 3 POETYK PSO clinical trials, Sotyktu demonstrated superiority over placebo and Otezla (apremilast) in skin clearance.
The approval was based on the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which evaluated the efficacy of Sotyktu in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis patients. Sotykto demonstrated efficacy at week 16 and week 24, and the effectiveness remained until 52 weeks. The primary endpoints were a static Physician Global Assessment (sPGA) score of 0 or 1 response and Psoriasis Area and Severity Index (PASI) 75 at week 16.
BMS announced that Sotyktu demonstrated a tolerable safety profile in the clinical trials.