Four months after receiving FDA approval, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib; Bristol Myers Squibb) for the treatment of adults with moderate-to-severe plaque psoriasis. The CHMP recommendation will now be reviewed by the European Commission.

Sotyktu, an oral medication taken once-daily, is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. The CHMP adopted the opinion based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktu in patients with moderate-to-severe plaque psoriasis versus placebo and twice-daily Otezla (apremilast), as well as an additional 2 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 3 POETYK PSO-1 and POETYK PSO-2 trials were published in the Journal of the American Academy of Dermatology.

“Patients living with moderate-to-severe psoriasis still experience debilitating symptoms and many remain untreated, undertreated or dissatisfied with current options, with a significant need for more effective and well-tolerated oral therapies,” Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb, said in a company news release. “Today’s positive CHMP opinion is an important advancement for patients in the EU to address the unmet needs they face, and we’re proud to be one step closer to bringing this first-in-class medicine with demonstrated durable efficacy to patients in need. We look forward to potentially seeing Sotyktu become the oral standard of care.”

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.