European Commission grants marketing authorization for Vumerity as an oral treatment for relapsing-remitting multiple sclerosis.
Vumerity is a next-generation fumarate that offers the convenience of an oral medication with the established efficacy and well-characterized safety of Tecfidera (dimethyl fumarate). Globally, an estimated 2.8 million people live with MS, with more than 1 million people in Europe living with the disease.
The EC’s approval of Vumerity is based on data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied in part on the well-established long-term efficacy and safety profile of Tecfidera.
The approval was also based on 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 relapsing-remitting MS. 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. Additionally, flushing was reported in 32.8% of Vumerity-treated patients and in 40.6% of Tecfidera treated patients. There were no serious events of flushing or discontinuations due to flushing in the study.
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