MS oral new medicine!

Biogen recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion recommending approval of Vumerity (diroximel fumarate), which is the next generation of oral fumarate.

Vumerity is a new type of oral fumaric acid drug with a unique chemical structure

In the United States, Vumerity was approved in October 2019 for the treatment of relapsing multiple sclerosis (RMS), including: clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease

Vumerity is an immunosuppressive agent.

Vumerity is an upgraded version of Bojian’s drug Tecfidera (dimethyl fumarate, DMF, dimethyl fumarate), which has improved gastrointestinal tolerance

CHMP’s positive review opinions are based on data from a pharmacokinetic bridging study comparing Vumerity and Tecfidera to establish bioequivalence, and partly based on Tecfidera’s established long-term safety and effectiveness characteristics

The structural difference between Vumerity and Tecfidera (Image source: vumerityhcp.

EVOLVE-MS-2 is a multicenter, double-blind, positive-drug-controlled, 5-week Phase III study in 506 patients with relapsing-remitting multiple sclerosis (RRMS).

It is worth mentioning that EVOLVE-MS-2 is the first study to directly compare the GI tolerance of two RMS treatment drugs

In addition, the results also showed that, compared with Tecfidera, patients treated with Vumerity: (1) The discontinuation rate due to GI adverse events (AE) was lower (0.

The above results of using the Patient Assessment Symptom Intensity Scale are supported by the lower incidence of GI AE reported by research investigators (Vumerity 34.

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Original source: CHMP Recommends VUMERITY® (diroximel fumarate) for Approval in the European Union as a Treatment for Relapsing-Remitting Multiple Sclerosis