Bristol Myers Squibb announced that the European Commission approved Sotyktu (deucravacitinib), a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. The approval was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla® (apremilast) at both 16 and 24 weeks, with responses maintained through 52 weeks. Additional data from the POETYK PSO long-term extension trial (LTE) also supported approval. The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment.
“Today’s approval is a landmark achievement as patients across Europe with moderate-to-severe plaque psoriasis will now have the opportunity to be treated with Sotyktu, the first once-daily oral option to provide significant symptom relief,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb. “Discovered in our own labs, Sotyktu has a unique mechanism of action and a well-demonstrated safety, efficacy and tolerability profile, representing a potential new oral standard of care, and demonstrating our ability to develop breakthrough, first-in-class treatments with the potential to transform people’s lives.”
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.”
The most commonly reported adverse reaction was upper respiratory infections (18.9%), most frequently nasopharyngitis. The incidence of serious infection in the Sotyktu group was 0.6% compared to 0.5% in the placebo group. The majority of infections were non-serious and mild to moderate in severity and did not lead to the discontinuation of Sotyktu. Infections occurred in 29.1% of patients in the Sotyktu group compared to 21.5% in the placebo group during the first 16 weeks. The rate of infections and serious infections in the Sotyktu group did not increase through Week 52. The longer-term safety profile of Sotyktu was similar and consistent with previous experience.
“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.”
Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.
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