FDA Accepts for Review Alkermes' and Biogen's NDA for Multiple Sclerosis Drug

Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) announced on 2/25/19 that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS). The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date in the fourth quarter of 2019. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY™, which has been conditionally accepted by the FDA and will be confirmed upon approval.