Vumerity Recommended for EU Approval as RRMS Treatment
A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union.
The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent to the European Commission, which will issue a final decision and has historically followed the committee’s recommendations.
“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,” Simon Faissner, MD, PhD, assistant professor in the department of neurology at Ruhr-University Bochum in Germany, said in a press release.
Vumerity, developed by Alkermes and Biogen, is an oral medication containing diroximel fumarate, an inactive molecule (prodrug) that gets converted into its active form, monomethyl fumarate (MMF), inside the body.
MMF, which is thought to work by reducing inflammation, is also the active ingredient of Tecfidera (dimethyl fumarate), an older medicine developed by Biogen that was first approved in the EU in 2014.
The CHMP’s positive opinion on Vumerity was supported by pharmacological data that showed that both Vumerity and Tecfidera lead to similar amounts of MMF in the body.
The opinion is also supported by data from a Phase 3 clinical trial called EVOLVE-MS-2 (NCT03093324), in which 506 people with RRMS were treated with either Tecfidera or Vumerity for five weeks. Results from the Biogen-sponsored study showed that treatment with Vumerity led to significantly fewer and less severe gastrointestinal side effects, which was associated with better quality of life.
Biogen is running an ongoing open-label clinical trial, EVOLVE-MS-1 (NCT02634307), to continue studying Vumerity’s long-term safety, tolerability, and effectiveness over nearly two years. Interim data presented earlier this year suggested that Vumerity showed a good safety profile as well as promising signs of efficacy.
“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,” said Alfred Sandrock, Jr., MD, PhD, Biogen’s head of research and development.
“We look forward to advancing Biogen’s portfolio and continuing to work with the MS community to address critical treatment challenges,” Sandrock added.
In the U.S., Vumerity has been approved to treat relapsing types of MS since late 2019. Tecfidera is currently the most prescribed oral MS therapy in the country, according to Biogen.