Posted by Michael Wonder on 30 Oct 2019
Biogen and Alkermes announce FDA approval of Vumerity (diroximel fumarate) for multiple sclerosis
30 October 2019 - Vumerity, a new oral treatment option for relapsing forms of multiple sclerosis, offers a combination of well-characterised efficacy, safety and tolerability.
Biogen and Alkermes today announced that the U.S. 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 commercialise Vumerity and intends to make it available in the United States in the near future.
The 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 Vumerity in patients with relapsing-remitting MS.
