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New drug application for diroximel fumarate in relapsing remitting MS submitted to US FDA

Drug companies Alkermes and Biogen have announced that Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), an oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).

Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated gastrointestinal tolerability due to its chemical structure as compared to dimethyl fumarate.

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.

“Diroximel fumarate was designed to provide patients with relapsing forms of MS a novel oral fumarate with a differentiated profile. The data encompassed in the regulatory package underscore diroximel fumarate’s potential to be a meaningful, new treatment option for the MS community,” said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President, medicines development and medical affairs at Alkermes.

Source: MS-UK, 18/12/18

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