Vumerity filed at FDA to treat relapsing-remitting MS. Biogen

Alkermes plc and Biogen Inc. announced that Alkermes has submitted a New Drug Application (NDA) to the FDA for diroximel fumarate (BIIB 098), 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 III 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.

Comment:BIIB 098 is designed to differ from Tecfidera in ways that would benefit patients, in particular by having fewer gastrointestinal side effects.