- Tuesday, January 31, 2023
- IPC GENERAL
- Drug Approvals, Industry
Bristol Myers Squibb (BMS) announced the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for once-daily Sotyktu (deucravacitinib) as a treatment for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. The CHMP decision was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials and an additional two years of data from the POETYK PSO long-term extension trial. The CHMP recommendation will be reviewed by the European Commission, and if approved, Sotyktu would be the first oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor in the European Union for the treatment of any disease.
