Benzinga | Sep 17, 2021 09:10AM EDT

Biogen Says CHMP Recommends VUMERITY For Approval In EU As Treatment For Relapsing-Remitting Multiple Sclerosis

Biogen Inc. (NASDAQ:BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), issued a positive opinion and has recommended granting marketing authorization for VUMERITY(r) (diroximel fumarate) in the European Union (EU). VUMERITY is a next-generation oral fumarate for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). An estimated 2.8 million people live with MS across the globe, with some European countries demonstrating the highest prevalence of MS in the world.1

"With MS, finding the right treatment option is as much about managing the clinical aspects of the disease as it is about how treatment fits into a person's life," said Simon Faissner, M.D., PhD, Assistant Professor at the Department of Neurology, Ruhr-University Bochum. "Today's CHMP opinion is a crucial step forward in providing an oral therapeutic option that is easy to integrate into a patient's daily life, which helps with ongoing care management."

The CHMP's positive opinion will now be referred to the European Commission (EC), which grants marketing authorizations for medicines in Europe.

"We look forward to advancing Biogen's portfolio and continuing to work with the MS community to address critical treatment challenges, including those that affect persistence and adherence to medication for this chronic and life-long disease," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "VUMERITY builds on our experience in MS and the established profile of TECFIDERA to bring a new oral option at a time when people with MS are making treatment decisions while considering other factors related to their ongoing care during the pandemic."

The positive CHMP opinion was based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA(r) (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 3 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.

VUMERITY was first approved by the U.S. Food and Drug Administration in October 2019 and is currently the number one prescribed oral MS therapy in the country. 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.2 Biogen continues to file regulatory submissions in other countries.