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Biogen's next-generation fumaric acid product, Vumerity, has been approved by the UK MHRA

 Last Update: 2022-02-25
 Source: Internet
 Author: User

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Biogen Vumerity (diroximel fumarate), a next-generation oral fumarate therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS), has been approved by the Medicines and Healthcare Products Administration (MHRA) in the United Kingdom

Vumerity is an upgraded version of Bojian's listed fumaric acid product Tecfidera (Chinese trade name: Tefida, generic name: dimethyl fumarate, dimethyl fumarate)

The approval of Vumerity by the MHRA and EC is based on data from a pharmacokinetic bridging study comparing Vumerity and Tecfidera, in part on Tecfidera's established favorable long-term efficacy and safety profile, and results from the EVOLVE-MS-2 study

The EVOLVE-MS-2 study is a large-scale, randomized, double-blind, 5-week, multicenter Phase 3 study to evaluate the gastrointestinal (GI) tolerability of Vumerity and Tecfidera in patients with RRMS

Vumerity was first approved by the US FDA in October 2019

Maha Radhakrishnan, M.

Reference source: MHRA authorises Vumerity for multiple sclerosis patients

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