Alkermes and Biogin have confirmed the submission of a New Drug Application (NDA) in the US 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,” said Craig Hopkinson, Chief Medical Officer and Senior Vice President, Medicines Development and Medical Affairs at Alkermes.
“The data encompassed in the regulatory package underscore diroximel fumarate’s potential to be a meaningful, new treatment option for the MS community.
“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.”