Alkermes has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for diroximel fumarate, a novel oral fumarate candidate to treat relapsing forms of multiple sclerosis (MS). If approved, it will be marketed by Biogen under the name Vumerity; the name has been conditionally accepted by the FDA. 

Diroximel fumarate (BIIB098, formerly known as ALKS 8700) is designed to rapidly convert to monomethyl fumarate in the body. It may potentially have a different effect on gastrointestinal (GI) tolerability compared to dimethyl fumarate due to its chemical structure. 

The NDA submission was supported by data from the phase 3 EVOLVE-1 trial that evaluated the long-term safety of diroximel fumarate in patients with relapsing-remitting MS (RRMS). Specifically, the trial evaluated the level of GI side effects, which are documented with other MS treatments. The full results of this safety study have not yet been released. 

Studies evaluating the treatment include: EVOLVE-MS-1 (NCT02634307), an open-label trial (N=900) investigating the 2-year safety of diroximel fumarate; and EVOLVE-MS-2 (NCT03093324), a 5-week, head-to-head GI tolerability study (N=420) with dimethyl fumarate. 

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Previously, diroximel fumarate demonstrated bioequivalence to Tecfidera (dimethyl fumarate; Biogen) in a phase 1 study (NCT02201849) that evaluated its safety, tolerability, and pharmacokinetics compared with Tecfidera and placebo. 

“The data encompassed in the regulatory package underscore diroximel fumarate’s potential to be a meaningful, new treatment option for the MS community,” stated Craig Hopkinson, MD, CMO and SVP, medicines development and medical affairs at Alkermes. 

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