NDA Submission to FDA by Alkermes (ALKS) and Biogen (BIIB)

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Alkermes (ALKS) and Biogen (BIIB) Announce Submission of NDA to FDA for Diroximel Fumarate in Multiple Sclerosis

Alkermes plc (ALKS) and Biogen Inc. (BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).

Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the NDA submission includes data from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS (RRMS) with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY™. This name has been conditionally accepted by the FDA and will be confirmed upon approval.

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