Bristol Myers Squibb’s (BMS’) plaque psoriasis treatment, Sotyktu (deucravacitinib), has been approved by the European Commission (EC) for adults with moderate-to-severe cases who are candidates for systemic therapy.
The approval, which follows 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 affecting at least 100 million people worldwide, including around 14 million in Europe and 7.5 million in the US. Up to 90% of patients with psoriasis have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.
Despite the availability of effective systemic therapy, BMS reports that many patients with moderate-to-severe psoriasis remain under-treated, untreated or dissatisfied with current treatment options.
The EC’s decision was supported by positive results from the 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 two years of data from the POETYK PSO long-term extension trial.
Sotyktu was shown to produce significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.
Samit Hirawat, chief medical officer, BMS, said: “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.”
Frida Dunger Johnsson, executive director, International Federation of Psoriasis Associations, said: “There has been an acute need for treatment options offering higher levels of efficacy for people living with moderate-to-severe psoriasis… 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.”
The therapy is already approved in major markets, including in the US for moderate-to-severe plaque psoriasis, as well as in Japan for plaque psoriasis, generalised pustular psoriasis and erythrodermic psoriasis.