Benzinga | Nov 16, 2021 09:22AM EST

Biogen Says The European Commission Grants Marketing Authorization For VUMERITY (diroximel fumarate) As Oral Treatment For Relapsing-Remitting Multiple Sclerosis



Biogen Inc. (NASDAQ:BIIB) today announced that the European Commission (EC) has granted marketing authorization for VUMERITY(r) (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS). VUMERITY is a next-generation fumarate that offers the convenience of an oral medication with the established efficacy and well-characterized safety of TECFIDERA(r) (dimethyl fumarate). Globally, an estimated 2.8 million people live with MS, with more than 1 million people in Europe living with the disease.1,2

"The approval of VUMERITY provides a new oral treatment option with low gastrointestinal discontinuation rates that may help patients to start and adhere to treatment," said Simon Faissner, M.D., PhD, Assistant Professor at the Department of Neurology, Ruhr-University Bochum. "This medication allows for MS patients in the EU to be treated without having to think about dietary restrictions or when to take a dose in relation to mealtimes which, when treating a chronic disease, may provide patients with additional flexibility in their daily lives."

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 3 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.

"This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment outcomes impacting their daily lives," said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. "The authorization of VUMERITY in the EU brings people with MS a new oral treatment option to meet their individual preferences and needs, with well-established efficacy and a positive GI tolerability profile that continues to be evaluated in the real-world setting."

VUMERITY was first approved by the U.S. Food and Drug Administration in October 2019 and is also approved in Great Britain and Switzerland. Since its launch in the U.S., real-world data have reinforced the positive GI tolerability profile of VUMERITY and confirmed that the experience demonstrated in clinical trials is consistent with clinical practice.3 Biogen continues to file regulatory submissions in other countries.