New Drug Application Novel for Oral Fumarate Accepted by Food and Drug Administration

The Food and Drug Administration (FDA) has accepted an application for diroximel fumarate (BIIB098; Alkermes, Waltham, MA and Biogen, Cambridge, MA) for the treatment of relapsing forms of multiple sclerosis (MS). eb. 25, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS). 

Approval is being sought under the the 505(b)(2) regulatory pathway, referencing data from Biogen on studies of dimethyl fumarate for the treatment of relapsing forms of MS, including the EVOLVE-MS-1 (NCT02634307) phase 3 open-label safety study. A head-to-head gastrointestinal tolerability study EVOLVE-MS-2 (NCT03093324) study is ongoing to examine whether the distinct chemical structure of diroximel fumarate affects gastrointestinal tolerability. Results of EVOLVE-MS-2 are expected later this year, and the FDA has set a target-action date in the fourth quarter of this year as well. 

If approved, Biogen intends to market diroximel fumarate under the brand name Vumerity, conditionally accepted by the FDA and to be confirmed if diroximel fumarate is approved.

"The NDA filing acceptance for diroximel fumarate further demonstrates the productive collaboration between Alkermes and Biogen and brings us closer to our shared goal of offering a new therapeutic option for people with MS," said Craig Hopkinson, MD, chief medical officer and senior vice president, medicines development and medical affairs at Alkermes. "We believe diroximel fumarate has the potential to be a meaningful new offering for patients with MS, and we look forward to continued engagement with the FDA throughout the review process."