Bristol-Myers announces european approval of Sotyktu

Bristol Myers Squibb announced that the European Commission has approved Sotyktu, or deucravacitinib, a selective tyrosine kinase 2, or TYK2, inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. The approval was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla, or apremilast, at both 16 and 24 weeks, with responses maintained through 52 weeks. Additional data from the POETYK PSO long-term extension trial, or LTE, also supported approval. The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment. Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that impacts approximately 14 million people in Europe. The most commonly reported adverse reaction was upper respiratory infections, 18.9%, most frequently nasopharyngitis. The incidence of serious infection in the Sotyktu group was 0.6% compared to 0.5% in the placebo group. The majority of infections were non-serious and mild to moderate in severity and did not lead to the discontinuation of Sotyktu. Infections occurred in 29.1% of patients in the Sotyktu group compared to 21.5% in the placebo group during the first 16 weeks. The rate of infections and serious infections in the Sotyktu group did not increase through Week 52. The longer-term safety profile of Sotyktu was similar and consistent with previous experience.