Diroximel fumarate for MS in US

January 6, 2020 0 By FM

The US FDA has approved Biogen Inc and partner Alkermes diroximel fumarate (Vumerity), for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

Diroximel fumarate is a novel oral fumarate with a distinct chemical structure.

The approval of diroximel fumarate was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing diroximel and dimethyl fumarate to establish bioequivalence, and relied, in part, on the FDA’s findings of safety and efficacy for dimethyl fumarate.

The NDA submission also included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, phase 3, single-arm, open-label, two-year safety study evaluating diroximel fumarate in patients with relapsing-remitting MS. 

Additional exploratory efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.

Once in the body, the rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.