A New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for diroximel fumarate (BIIB098/Vumerity; Alkermes PLC, Waltham, MA), a novel oral fumarate in development for treating relapsing forms of multiple sclerosis (MS). The NDA submission from Alkermes PLC includes data from EVOLVE-MS-1 (NCT02634307), a 2-year, pivotal phase 3 trial that evaluated long-term safety of diroximel fumarate in patients with relapsing-remitting MS, with about 700 patients dosed with the drug.
The key components in the development of diroximel fumarate include the EVOLVE-MS-1 study and pharmacokinetic bridging studies that compared diroximel fumarate and dimethyl fumarate. Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may offer greater GI tolerability than dimethyl fumarate due to its chemical structure.
"Diroximel fumarate was designed to provide patients with relapsing forms of multiple sclerosis a novel oral fumarate with a differentiated profile,” said Craig Hopkinson, MD, 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.”Next Story