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# Biogen Gains Vumerity Approval for MS
- URL: https://www.fdaweb.com/biogen-gains-vumerity-approval-for-ms/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145378

FDA has approved a Biogen 505 (b)(2) NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The NDA included data from pharmacokinetic bridging studies comparing Vumerity and the company’s Tecfidera to establish bioequivalence, and relied, in part, on the agency’s earlier safety and efficacy findings on Tecfidera.

The NDA also included interim exposure and safety findings from EVOLVE-MS-1, an ongoing Phase 3 safety study evaluating Vumerity in patients with relapsing-remitting MS. “Interim results from EVOLVE-MS-1 at the time of NDA submission included a low overall rate of Vumerity treatment discontinuation due to adverse events (6.3%), and a rate of less than one percent of patients who discontinued Vumerity treatment due to gastrointestinal (GI) adverse events,” the company says.