BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Sotyktu (deucravacitinib) for Plaque Psoriasis
- The opinion was based on the P-III trials (POETYK PSO-1 & 2) results evaluating the safety & efficacy of Sotyktu (6mg, qd) vs PBO and Otezla (30mg, BID) in 666 & 1020 patients along with an additional 2yr. results from the (POETYK PSO) long-term extension trial
- The results showed significant & clinical improvements in skin clearance, symptom burden & QoL. The therapy was well-tolerated with a low rate of discontinuation due to AEs & both trials results were published in the JAAD
- Sotyktu was approved in the US for adults with mod. to sev. PsO in Sept 2022, and in Japan for PsO, GPP & erythrodermic psoriasis in Sept 2022. The therapy is currently under regulatory review by other health authorities globally
Ref: Businesswire | Image: BMS
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