Alkermes and Biogen have announced that Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for diroximel fumarate.
The drug is a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).
If approved, Biogen intends to market diroximel fumarate under the brand name Vumerity, which has been conditionally accepted by the FDA.
The FDA submission follows a Phase III pivotal trial in which approximately 700 patients were dosed with diroximel fumarate, during a two-year safety study in relapsing-remitting MS patients.
Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated gastrointestinal tolerability due to its chemical structure, compared to dimethyl fumarate, which helps decrease the number of episodes of worsening MS.
“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.”