Bristol Myers Squibb Sotyktu gets European Commission nod for adults with plaque psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that impacts approximately 14 million people in Europe. Up to 90% of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. Current therapies include topicals, orals and biologics. Patients may prefer oral therapies, and many patients and physicians are looking for additional efficacious and tolerable options.

“The approval of Sotyktu is groundbreaking for the psoriasis community because we now have a tolerable, highly efficacious, once-daily oral treatment option that does not require lab monitoring,” said Diamant Thaçi, MD, PhD, director and full professor, Institute and Comprehensive Center for Inflammation Medicine, University Lübeck, Germany. “The Phase 3 POETYK-PSO clinical trials showed that Sotyktu demonstrated significant, durable efficacy across multiple key endpoints, including skin clearance and symptom burden. The results are particularly meaningful for dermatologists and patients who have been waiting for a more effective and convenient oral therapy to help manage this serious, chronic, immune-mediated disease.”

“Psoriasis can greatly impact one’s life physically, emotionally and mentally, with symptoms, such as visible plaques and itching, and feelings of self-stigma and isolation,” said Frida Dunger Johnsson, Executive Director, IFPA (International Federation of Psoriasis Associations). “There has been an acute need for treatment options offering higher levels of efficacy for people living with moderate-to-severe psoriasis, many of whom remain untreated, undertreated or dissatisfied with current medicines. We are thrilled that we now have the first once-daily oral therapy to help people with plaque psoriasis and physicians as they work together toward the goal of relieving symptoms and improving their disease.”

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