Biogen & Alkermes have announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate in multiple sclerosis (MS).
The drug, diroximel fumarate, is a novel oral fumarate in development for the treatment of relapsing forms of MS.
The approval has a target action date in the fourth quarter of 2019, and if approved, Biogen intends to market diroximel fumarate under the brand name Vumerity, which has been conditionally accepted by the FDA and will be confirmed upon approval.
"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, 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."
The NDA submission includes data from EVOLVE-MS-1, a Phase III, open-label, two-year safety study in relapsing-remitting MS (RRMS) patients.
RRMS is the most common form of multiple sclerosis. About 85% of people with MS are initially diagnosed with RRMS, and people with RRMS have temporary periods called relapses, flare-ups or exacerbations, when new symptoms appear.