BMS' deucravacitinib applications accepted by US and EU regulators
Bristol Myers Squibb (NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib to treat moderate to severe plaque psoriasis.
The US drugmaker could face a long wait for a decision in the case of its US application, with the FDA assigning a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022.
"Many remain undertreated or even untreated"These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labor and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
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