Alkermes, Biogen Submits NDA for Diroximel Fumarate

Alkermes and Biogen announced Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).

Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the NDA submission includes data from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS (RRMS) with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY. This name has been conditionally accepted by the FDA and will be confirmed upon approval.

"Diroximel fumarate was designed to provide patients with relapsing forms of multiple sclerosis a novel oral fumarate with a differentiated profile. The data encompassed in the regulatory package underscore diroximel fumarate’s potential to be a meaningful, new treatment option for the MS community," said Craig Hopkinson, M.D., chief medical officer and senior vice president, medicines development and medical affairs at Alkermes. "This NDA submission is an important step in our collaboration with Biogen for diroximel fumarate, and we look forward to working together to bring this potential new medicine to patients and healthcare providers."

"The filing of diroximel fumarate by our partners at Alkermes demonstrates our enduring commitment to people living with MS and builds on our established track record as a leader in the industry," said Michael Ehlers, M.D., Ph.D., executive vice president, research & development at Biogen. "MS is a heterogeneous disease, and while there are a number of approved therapies available today, continued treatment advances remain an important priority."

The key components of the clinical development program of diroximel fumarate include the EVOLVE-MS-1 study, a two-year safety study in relapsing-remitting MS (RRMS) patients, along with pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate. In addition, Alkermes is conducting the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal (GI) tolerability study versus dimethyl fumarate.

Diroximel fumarate (BIIB098) is a novel oral fumarate candidate in development for the treatment of relapsing forms of MS. Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated GI tolerability due to its chemical structure as compared to dimethyl fumarate.

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