Bristol-Myers’ Sotyktu recommended for approval in psoriasis by Europe’s CHMP

Bristol Myers announced that the Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency has recommended the approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union – EU -. The CHMP adopted this positive opinion based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Sotyktu demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla. Sotyktu was well-tolerated with a low rate of discontinuation due to adverse events. The FDA approved Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in September 2022, and Japan’s Ministry of Health, Labour and Welfare approved Sotyktu for the treatment of adults with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis who have had an inadequate response to conventional therapies in September 2022. In addition to the European Medicines Agency, Sotyktu is also under regulatory review by other health authorities around the world for the treatment of moderate-to-severe plaque psoriasis.