USFDA accepts Bristol Myers Squibb’s new drug application for ‘Deucravacitinib’ to treat plaque psoriasis
Bristol Myers Squibb, on Monday, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ‘Deucravacitinib’ for the treatment of adults with moderate to severe plaque psoriasis. The company’s Marketing Authorization Application (MAA) for the same medicine has also got approval from the European Medicines Agency (EMA).
Deucravacitinib would be the first oral tyrosine kinase 2 inhibitor, approved for the treatment of any disease The NDA for ‘Deucravacitinib’ has already been accepted by Japan’s Ministry of Health, Labour, and Welfare for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis, and erythrodermic psoriasis.
“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,” said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb.
Jonathan continues saying, “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 EMA with the goal of bringing deucravacitinib to patients and physicians as quickly as possible.”
The regulatory applications are based on positive results from the trials, which evaluated once-daily Deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and Apremilast (another drug for skin diseases). The new drug demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared to placebo and Otezla.