CHMP recommends Vumerity to treat relapsing-remitting multiple sclerosis.- Biogen.

The positive CHMP opinion was based on data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera (dimethyl fumarate) to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied in part on the well-established long-term safety and efficacy profile of Tecfidera.

The CHMP also assessed findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase III study to evaluate the gastrointestinal (GI) tolerability of Vumerity compared to Tecfidera in patients with RRMS. In EVOLVE-MS-2, the rate of overall treatment discontinuation was lower in participants treated with Vumerity compared to those treated with Tecfidera (1.6% compared to 6%, respectively). The difference in the discontinuation rates due to GI tolerability was 0.8% for Vumerity compared to 4.8% for Tecfidera..