The approval is based on results from the pivotal 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 ® (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. 1,2 Sotyktu is not recommended for use in combination with other potent immunosuppressants. Food and Drug Administration (FDA) approved Sotyktu ™(deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Sotyktu has a well-demonstrated safety and tolerability profile based on the POETYK PSO clinical trials Pivotal Phase 3 POETYK PSO clinical trials demonstrated superior efficacy of once-daily Sotyktu over placebo and twice-daily Otezla ® (apremilast) in improving skin clearance Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years
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