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Alkermes Announces NDA Filing Acceptance For Diroximel Fumarate - Quick Facts

Alkermes plc (ALKS) and Biogen Inc. (BIIB) announced the U.S. FDA has accepted for review the New Drug Application for diroximel fumarate (BIIB098), an oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. The NDA has been assigned a PDUFA target action date in the fourth quarter of 2019.

Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, referencing Biogen's dimethyl fumarate data. If approved, Biogen intends to market diroximel fumarate under the brand name, VUMERITY.

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