The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of diroximel fumarate (Vumerity, Biogen Inc) for adults with relapsing-remitting multiple sclerosis (MS).
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 and 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.
“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, MD, PhD, Department of Neurology, Ruhr-University Bochum, Bochum, Germany, said in a statement from Biogen.
The CHMP positive opinion on diroximel fumarate 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,” Faissner said.
The CHMP’s positive opinion will now be referred to the European Commission, which grants marketing authorizations for medicines in Europe.
Diroximel fumarate was first approved by the US Food and Drug Administration 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.
For more Medscape Neurology news, join us on Facebook and Twitter
Source: Read Full Article