Relapsing Multiple Sclerosis Drug Approved By FDA

The US Food and Drug Administration (FDA) has announced that VUMERITY™ (diroximel fumarate) has been approved. The drug is for the treatment of patients with relapsing forms of multiple sclerosis (MS) and will be available in the US soon.

VUMERITY, produced by Biogen and Alkermes, is a novel oral fumarate with a distinct chemical structure approved for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.

The FDA approval of the drug was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA^® to establish bioequivalence and relied, in part, on the FDA’s findings of safety and efficacy for TECFIDERA.-European Pharmaceutical Review