European Medicines Agency recommends Sotyktu for adults with plaque psoriasis

The European Medicines Agency has recommended the approval of Sotyktu for the treatment of adults with moderate to severe plaque psoriasis, Bristol Myers Squibb announced in a press release.

Approved by the FDA in September 2022, Sotyktu (deucravacitinib) is a first-in-class, selective, allosteric tyrosine kinase 2 inhibitor that is administered orally, once-daily for the treatment of moderate to severe plaque psoriasis. The recommendation for Sotyktu from the agency’s Committee for Medicinal Products for Human Use (CHMP) is specifically for candidates of systemic therapy.

“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, Bristol Myers Squibb chief medical officer, said in the release. “Today’s positive CHMP opinion is an important advancement for patients in the [European Union] 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.”

The agency’s recommendation is supported by data from two pivotal phase 3 trials, POETYK PSO-1 and POETYK PSO-2, in which Sotyktu was compared with placebo and twice-daily Otezla (apremilast). These studies showed that Sotyktu outperformed both placebo and Otezla in skin clearance, symptom alleviation and quality of life improvement. Additionally, Sotyktu was well tolerated and had a low rate of discontinuation due to adverse events.

The committee’s recommendation is currently under review by the European Commission.