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  • FDA accepts NDA for BMS 986165, and EMA validates ...

FDA accepts NDA for BMS 986165, and EMA validates MAA, for moderate to severe plaque psoriasis.

Read time: 1 mins
Published:30th Nov 2021
Bristol Myers Squibb announced that the FDA has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for BMS 986165 (deucravacitinib) for the treatment of adults with moderate to severe plaque psoriasis.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once daily deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and 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 was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities. Primary results were presented at the American Academy of Dermatology Virtual Meeting Experience in April 2021, and additional analyses were presented at the European Academy of Dermatology and Venereology 30th Anniversary Congress in September 2021.

Condition: Psoriasis
Type: drug

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