European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
Biogen has announced that the European Commission (EC) has granted marketing authorisation for Vumerity® (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
Vumerity is an oral fumarate with a distinct chemical structure from Tecfidera® (dimethyl fumarate), for the treatment of relapsing forms of MS in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
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, randomised, double-blind, five-week, multi-centre Phase III 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 percent compared to 6 percent, respectively).
The difference in the discontinuation rates due to GI tolerability was 0.8 percent for Vumerity compared to 4.8 percent for Tecfidera. Additionally, flushing was reported in 32.8 percent of Vumerity-treated patients and in 40.6 percent of Tecfidera treated patients. There were no serious events of flushing or discontinuations due to flushing in the study.
Vumerity was first approved by the US Food and Drug Administration (FDA) in October 2019 and is also approved in Great Britain and Switzerland.
“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,” stated Dr Simon Faissner at Ruhr-University Bochum, Germany. “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.”