EMA's CHMP approval opinions in January 2023

Although there were several positive recommendations for label extensions on already approved medicines, January proved a thin month for novel drug approvals in the European Union, with just one new drug and three for generics.  The recommendation will now be reviewed by the European Commission.

The European Medicines Agency’s (EME) human medicines committee (CHMP) recommended granting a marketing authorization for Sotyktu (deucravacitinib), developed by US pharma major Bristol Myers Squibb (NYSE: BMY), for the treatment of moderate to severe plaque psoriasis in adults, a skin disease causing red, scaly patches.

The benefits of Sotyktu are its ability to improve the skin condition, measured by the proportion of patients achieving a PASI 75 response (at least a 75% reduction in the Psoriasis Area and Severity Index) and a static Physician’s Global Assessment (sPGA) of clear or almost clear (0 or 1) in two Phase III multicenter, randomized, double-blind, placebo- and apremilast-controlled clinical studies. The most common side effects are upper respiratory infections, most frequently nasopharyngitis.