CHMP Recommends VUMERITY (diroximel fumarate) for Approval in the European Union as a Treatment for Relapsing-Remitting Multiple Sclerosis

• VUMERITY is a next-generation oral fumarate with a well-characterized efficacy and safety profile
• Data from the Phase 3 EVOLVE-MS-2 study have demonstrated that treatment with VUMERITY results in low discontinuation rates due to its gastrointestinal (GI) tolerability profile
• Upon approval, VUMERITY will offer a new oral option for MS patients as they consider treatment initiation in the context of the COVID-19 environment
  

CAMBRIDGE, Mass., Sept. 17, 2021 (GLOBE NEWSWIRE) --  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 (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.”