Vumerity FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 6, 2020.
FDA Approved: Yes (First approved October 29, 2019)
Brand name: Vumerity
Generic name: diroximel fumarate
Dosage form: Delayed-Release Capsules
Company: Biogen Inc.
Treatment for: Multiple Sclerosis
Vumerity (diroximel fumarate) is a novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS).
- Vumerity is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- In clinical studies, Vumerity demonstrated efficacy similar to Tecfidera (dimethyl fumarate), but with improved patient-reported gastrointestinal tolerability.
- Vumerity capsules are taken twice daily and must be swallowed whole. Flushing and stomach problems can be common especially at the start of treatment, but taking Vumerity with food (avoiding high-fat, high-calorie meals or snacks) may help reduce flushing.
- Common side effects include flushing, redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion.
Development timeline for Vumerity
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