FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Biogen, Alkermes Earn FDA Approval for Vumerity for Multiple Sclerosis

Nov. 11, 2019
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The FDA has approved Biogen and Alkermes’ Vumerity (diroximel fumarate) to treat relapsing forms of multiple sclerosis (MS).

The approval was based on studies that demonstrated the drug’s bioequivalence to Biogen’s Tecfidera (dimethyl fumarate), which is also approved to treat relapsing MS, as well as an ongoing phase 3 trial that studied patients with relapsing-remitting MS.

Interim results of the trial showed a low overall rate of discontinuation due to adverse events. Less than one percent of patients discontinued treatment due to gastrointestinal adverse events.

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