Benzinga | Nov 30, 2021 04:02PM EST

Bristol Myers' Deucravacitinib Under FDA Review For Plaque Psoriasis

The FDA has accepted for review Bristol Myers Squibb & Co's (NYSE:BMY) deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.

* The European Medicines Agency has also validated the deucravacitinib marketing application for plaque psoriasis.

* The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022.

* The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib versus placebo and Amgen Inc's (NASDAQ:AMGN) Otezla (apremilast).

* Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared to placebo and Otezla.

* Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor.

* See here Benzinga's Full FDA Calendar.

* Price Action: BMY shares are down 1.02% at $55.96 during the market session on the last check Monday.