EC 批准百时美施贵宝的 Sotyktu 用于治疗斑块状银屑病

Bristol-Myers Squibb's (BMS) plaque psoriasis treatment Sotyktu (deucravacitinib) has received approval from the European Commission (EC) for adults with moderate to severe cases who are candidates for systemic treatment.

The approval, based on a recommendation from the Committee for Medicinal Products for Human Use earlier this year, makes Sotyktu the first oral, selective allosteric tyrosine kinase 2 inhibitor in the EU for the treatment of any disease.

Psoriasis is a chronic, systemic immune-mediated disease that affects at least 100 million people worldwide, including approximately 14 million in Europe and 7.5 million in the United States. Up to 90 percent of people with psoriasis have plaque psoriasis, which is characterized by distinct round or oval plaques that are often covered in silvery-white scales.

Despite the availability of effective systemic treatments, the BMS reports that many patients with moderate to severe psoriasis remain undertreated, untreated or are dissatisfied with current treatment options.

The EC's decision is supported by positive results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated the efficacy of once-daily Sotyktu compared with placebo and twice-daily Otezla (apremilast) in patients with moderate-to-severe plaque psoriasis, as well as two additional years of data from the POETYK PSO long-term extension trial.

Sotyktu produced significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared with placebo and Otezla.

Samit Hirawat, chief medical officer at BMS, said: “Today’s approval is a landmark achievement as European patients 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 relief of symptoms.”

Frida Dunger Johnsson, executive director of the International Federation of Psoriasis Societies, said: "There is an urgent need for treatment options that provide higher levels of efficacy for patients with moderate to severe psoriasis... We are pleased that we now have the first once-daily oral therapy to help patients with plaque psoriasis and their physicians work together to achieve the goals of symptom relief and disease improvement."

The therapy is approved in major markets, including in the United States for moderate to severe plaque psoriasis, and in Japan for plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis.