CHMP recommends approval of Sotyktu in plaque psoriasis.- Bristol Myers Squibb

The CHMP adopted this positive opinion based on results from the pivotal Phase III POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktuin patients with moderate-to-severe plaque psoriasis versus placebo and twice-daily Otezla (apremilast), as well as an additional two years of data from the POETYK PSO long-term extension trial. 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 most common adverse reactions (?1% of patients on Sotyktu) included upper respiratory infections, herpes simplex infections, oral ulcers, folliculitis and acneiform rash. The results of the Phase III POETYK PSO-1 and POETYK PSO-2 trials were published in the Journal of the American Academy of Dermatology.

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.