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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
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

DateArticle
Oct 30, 2019Approval  FDA Approves Vumerity (diroximel fumarate) for Multiple Sclerosis
Jul 30, 2019Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis
May 30, 2019New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis
Feb 25, 2019Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis
Dec 17, 2018Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis

Further information

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