Bristol Myers Squibb’s plaque psoriasis treatment recommended by CHMP

Bristol Myers Squibb (BMS) has announced that its plaque psoriasis treatment Sotyktu (deucravacitinib) has been recommended by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for moderate to severe cases.

Sotyktu is specifically indicated for adult patients who are candidates for systemic therapy and, if approved, would be the first oral, selective, allosteric tyrosine kinase-2 inhibitor in the EU for the treatment of any disease.

Plaque 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.

Almost a quarter of patients with psoriasis have cases that are considered moderate to severe, with many of these patients remaining undertreated, untreated, or dissatisfied with current treatment options, reports BMS.

Samit Hirawat, the company’s Chief Medical Officer, said: “Today’s positive CHMP opinion is an important step forward for patients in the EU to address the unmet needs they are facing and we are proud to announce this first-in – Class medicine with proven lasting effectiveness for patients in need.”

The CHMP’s decision was based on the results of the pivotal phase 3 studies POETYK PSO-1 and POETYK PSO-2, which evaluated once-daily Sotyktu in patients with moderate to severe plaque psoriasis compared to placebo and twice-daily Otezla (apremilast). was investigated. and an additional two years of data from the POETYK-PSO long-term extension study.

Sotyktu has been shown to produce significant and clinically meaningful improvements in skin clearing, symptom burden and quality of life compared to placebo and Otezla.

The therapy is already approved in key markets including the US for moderate to severe plaque psoriasis and Japan for plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis.

BMS also noted that in addition to the EMA, Sotyktu is under regulatory review by other health authorities for the treatment of moderate to severe plaque psoriasis.

The company also received a CHMP recommendation this month for Reblozyl (luspatercept) for the treatment of adult patients with anemia associated with non-transfusion dependent beta-thalassemia.

The decision was supported by the results of the phase 2 BEYOND study, which showed that Reblozyl maintained hemoglobin elevation in 77% of patients regardless of their baseline hemoglobin status.

Noah Berkowitz, Senior Vice President, Hematology Development at BMS, said: “The potential approval of Reblozyl for patients with non-transfusion-dependent beta-thalassemia represents an important development in the EU, where several countries have high prevalence and more people live from affected by the disease”