First oral allosteric TYK2 inhibitor recommended in EU

Plaque psoriasis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.  

Sotyktu, an oral medication taken once-daily, is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.  

The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). 

“Patients living with moderate-to-severe psoriasis still experience debilitating symptoms and many remain untreated, undertreated or dissatisfied with current options, with a significant need for more effective and well-tolerated oral therapies,” said Samit Hirawat, Chief Medical Officer, Bristol Myers Squibb. 

The positive opinion is based on results from the Phase III POETYK PSO-1 and POETYK PSO-2 trials, in which Sotyktu demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla. 

The drug is already approved in the US for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is also available in Japan for adults with plaque psoriasis, generalised pustular psoriasis, and erythrodermic psoriasis who have had an inadequate response to conventional therapies. 

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