FDA approves Vumerity for relapsing forms of multiple sclerosis.- Biogen + Alkermes

Biogen Inc and Alkermes announced that the FDA approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the United States in the near future.

The FDA approval of Vumerity was based on a New Drug Application (NDA) submitted under the 505(b) 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. The NDA submission also included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, Phase III, single-arm, open-label, two-year safety study evaluating Vumerity in patients with relapsing-remitting MS. Interim results from EVOLVE-MS-1 at the time of NDA submission included a low overall rate of Vumerity treatment discontinuation due to adverse events (6.3 percent), and a rate of less than one percent of patients who discontinued Vumerity treatment due to gastrointestinal (GI) adverse events. Additional exploratory efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.