Diroximel Fumarate (Vumerity) Cleared for MS in Europe

The European Commission (EC) has approved diroximel fumarate (Vumerity, Biogen Inc) for treatment of adults with relapsing-remitting multiple sclerosis (MS).

The approval follows a thumbs-up from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September, as reported by Medscape Medical News.  

Diroximel fumarate is similar to dimethyl fumarate (Tecfidera, Biogen Inc) in efficacy but has a unique chemical structure that may induce less irritation to the gastrointestinal (GI) tract, as demonstrated in the EVOLVE-MS-2 trial.

In the trial, as previously reported by Medscape Medical News, the overall proportion of patients with adverse events leading to study discontinuation was 1.6% for diroximel fumarate compared with 6% for dimethyl fumarate.  

Of those, the proportion of patients who discontinued because of GI adverse events during the treatment period was 0.8% for diroximel fumarate and 4.8% for dimethyl fumarate.

The approval of diroximel fumarate provides “a new oral treatment option with low gastrointestinal discontinuation rates that may help patients to start and adhere to treatment,” Simon Faissner, MD, PhD, Department of Neurology, Ruhr-University Bochum, Germany, said in a Biogen news release announcing EC approval.

“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,” Faissner said.

Diroximel fumarate was first approved by the US Food and Drug Administration (FDA) in October 2019 for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease, as reported by Medscape Medical News.

It was also recently approved in Switzerland and the UK.

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