FDA, European Medicines Agency accept deucravacitinib applications for plaque psoriasis

The FDA has accepted a New Drug Application, while the European Medicines Agency validated a Marketing Authorization Application for deucravacitinib for the treatment of plaque psoriasis, Bristol Myers Squibb announced in a press release.

The decisions are based on data from the POETYK PSO-1 and POETYK PSO-2 trials, which evaluated the efficacy of deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo and Otezla (apremilast).

“There is a strong need for more effective and well-tolerated oral therapies for people living with moderate to severe plaque psoriasis, as many remain undertreated or even untreated,” Jonathan Sadeh, MD, MSc, senior vice president of immunology and fibrosis development at Bristol Myers Squibb, said in the release. “Findings from the pivotal POETYK PSO trials demonstrate the potential of deucravacitinib to elevate the oral standard of care for individuals who are candidates for systemic therapy. We look forward to continuing to work with the FDA and [European Medicines Agency] with the goal of bringing deucravacitinib to patients and physicians as quickly as possible.”

The FDA set a Prescription Drug User Fee Act goal date of Sept. 10, 2002.