BioCentury
ARTICLE | Clinical News

FDA accepts NDA for multiple sclerosis prodrug from Alkermes, Biogen

February 28, 2019 2:36 AM UTC

Alkermes plc (NASDAQ:ALKS) said FDA accepted for review an NDA for diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis. The PDUFA date is in 4Q19. The company submitted the NDA submitted under under section 505(b)(2) of the Food, Drug and Cosmetic Act.

Partner Biogen Inc. (NASDAQ:BIIB) intends to market the product under the brand name Vumerity...

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