The approval follows a thumbs up from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September according to reported by Medscape Medical News.
Diroximel fumarate is similar in effectiveness to Dimethyl Fumarate ( Tecfidera, Biogen Inc) but has a unique chemical composition that can cause less irritation to the gastrointestinal tract (GI) as was demonstrated in the EVOLVE MS-2 trial.
In the trial that was previously published by Medscape Medical News, the proportion of patients who experienced adverse events that resulted in discontinuation of the study was 1.6 percent for diroximel fumarate compared with 6 percent for dimethyl fumarate.
Of these, the percentage of patients who quit treatment due to GI adverse events during the treatment period was 0.8% for diroximel fumarate, and 4.8% for dimethyl fumarate.
The approval of diroximel fumarate is “a new oral treatment option with low gastrointestinal discontinuation rates that may help patients to start and maintain their treatment,” Simon Faissner, MD, PhD, Department of Neurology, Ruhr-University Bochum, Germany 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, could provide patients with more flexibility in their daily lives,” Faissner said.
Diroximel fumarate was approved by the US Food and Drug Administration (FDA) in October of 2019 for the treatment of the relapsing form of MS which includes the clinically isolated syndrome, relapsing-remitting MS and active secondary progressive diseases, as reported by Medscape Medical News.
It was recently approved in Switzerland as well as the UK.
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Content Source: https://www.medscape.com/viewarticle/963179?src=rss