The European Commission gave its stamp of approval for Vumerity (diroximel fumarate), developed by Biogen, as an oral treatment for patients with relapsing-remitting multiple sclerosis (RRMS).
The European Commission granted marketing authorization to Biogen for its next-generation oral fumarate treatment, Vumerity (diroximel fumarate), as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union.
The drug will provide patients the convenience of an oral medication with efficacy and safety profiles that are similar to those of Tecfidera (dimethyl fumarate), another oral therapy for MS, according to the company. An estimated 2.8 million people globally live with MS, of whom more than 1 million reside in Europe.
“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….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,” said Simon Faissner, MD, PhD, assistant professor at the Department of Neurology at Ruhr-University Bochum in Germany, in a statement.
The authorization was based on data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera to establish bioequivalent exposure of monomethyl fumarate, which is the active metabolite of the drugs. The study also relied in part on the well-established long-term efficacy and safety of Tecfidera.
Additionally, the approval was partly based on the findings from the EVOLVE-MS-2 study, a large, randomized, double-blind, 5-week, multicenter phase 3 analysis designed to evaluate the gastrointestinal (GI) tolerability of Vumerity compared with Tecfidera in patients with RRMS. The study found that the rate of overall treatment discontinuation was lower in patients treated with Vumerity than in those treated with Tecfidera (1.6% vs 6%, respectively). The difference in the discontinuation rates due to GI tolerability was also lower for the Vumerity treatment arm compared with the Tecfidera arm (0.8% vs 4.8%, respectively).
Flushing was also reporting in 32.8% of the patients treated with Vumerity compared with 40.6% of the patients treated with Tecfidera. No serious events of flushing or discontinuations due to flushing were observed in the analysis.
Vumerity was approved for use by the FDA in October 2019 and has also been approved in Great Britain and Switzerland. Since the drug launched on the US market, real-world data supported the positive GI tolerability profile of Vumerity and confirmed that the experience demonstrated in clinical trials is consistent with clinical practice. Biogen said that it will continue to file for regulatory approval in other countries.
“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….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,” said Maha Radhakrishnan, MD, chief medical officer of Biogen, in a statement.
The European Commission grants marketing authorization for Vumerity® (diroximel fumarate) as oral treatment for relapsing-remitting multiple sclerosis. News release. Biogen. November 16, 2021. Accessed November 17, 2021. https://investors.biogen.com/news-releases/news-release-details/european-commission-grants-marketing-authorization-vumerityr