Alkermes and Biogen said the FDA will check their novel oral fumarate in development for diroximel fumarate (BIIB098), for the treatment of relapsing forms of multiple sclerosis (MS).
According to the press release, the NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date in the fourth quarter of 2019.
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.
Craig Hopkinson, chief medical officer and senior vice president at Alkermes believes diroximel fumarate has the potential to be a meaningful new offering for patients with MS.
Michael Ehlers, executive vice president, research and development at Biogen, said: “We are encouraged by the FDA’s acceptance of the NDA for diroximel fumarate, which we believe could help elevate the treatment of this complex and often debilitating disease.”