FDA Clears More Tolerable Diroximel Fumarate (Vumerity) for MS

Megan Brooks

October 30, 2019

The US Food and Drug Administration (FDA) has approved diroximel fumarate (Vumerity, Biogen/Alkermes) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease, the companies have announced.

Diroximel fumarate is similar to dimethyl fumarate (Tecfidera, Biogen) in efficacy but has a unique chemical structure that may induce less irritation to the gastrointestinal (GI) tract, as demonstrated in the EVOLVE-MS-2 trial

As previously reported by Medscape Medical News, EVOLVE-MS-2 was a phase 3, multicenter, double-blind, active-controlled, 5-week study evaluating GI tolerability of diroximel fumarate (462 mg twice daily) compared with dimethyl fumarate (240 mg twice daily) in 506 patients with RRMS.

The study achieved its primary endpoint, with patients taking diroximel fumarate experiencing statistically significantly fewer days of GI symptoms with a symptom intensity score of 2 or greater on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) compared with dimethyl fumarate (P = .0003), according to top-line results released last summer.

The overall incidence of investigator-reported GI adverse events, as well as the rate of treatment discontinuation as a result of these side effects, was low.

The most common adverse events (AEs) reported in the study for both treatment groups were flushing, diarrhea, and nausea (32.8%, 15.4%, and 14.6%, respectively, for diroximel fumarate; 40.6%, 22.3%, and 20.7%, respectively, for dimethyl fumarate).

The overall proportion of patients with AEs leading to study discontinuation was 1.6% for diroximel fumarate and 6% for dimethyl fumarate. Of those, the proportion of patients who discontinued because of GI adverse events during the treatment period was 0.8% for diroximel fumarate and 4.8% for dimethyl fumarate.

"MS is a heterogeneous disease, and real-world patient circumstances can vary, reinforcing the benefits of having therapeutic choices to support the diverse range of treatment considerations," said Robert Naismith, MD, professor of neurology at Washington University School of Medicine in St. Louis, Missouri, in a Biogen/Alkermes news release announcing FDA approval. 

"Throughout its clinical development program, Vumerity has demonstrated a desirable therapeutic profile, making it a compelling new option for patients," said Naismith.

Craig Hopkinson, MD, chief medical officer at Alkermes, said the approval of Vumerity for relapsing MS "marks the culmination of a multi-year development program and is the latest milestone in our mission to develop new treatments for patients living with chronic central nervous system disorders."

"We are grateful to the patients and study investigators who have participated in our Vumerity clinical trials and we look forward to working with our collaboration partners at Biogen to make this new treatment available to patients," said Hopkinson.

For more Medscape Neurology news, join us on Facebook and Twitter


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.