Biogen Inc. — Vumerity FDA Review (NDA211855, ORIG 1, 2019)

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This clinical review recommends approval for Biogen's Vumerity (diroximel fumarate) for adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. As a 505(b)(2) application, Vumerity relies on the established efficacy and safety of Tecfidera (dimethyl fumarate) due to their shared active metabolite, monomethyl fumarate (MMF). Multiple Phase 1 studies in healthy adults and Phase 3 studies (ALK8700-A301, ALK8700-A302) in RMS patients assessed Vumerity's pharmacokinetics, bioavailability, and safety. These studies consistently showed a safety profile similar to Tecfidera, with common adverse events including mild to moderate flushing and gastrointestinal symptoms. Specific safety concerns like lymphopenia and transaminase elevations were also comparable. Labeling recommendations include considerations for administration with high-fat meals or alcohol and contraindications for severe renal impairment. Vumerity will also leverage Tecfidera's post-marketing requirements.

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