By Colin Kellaher

 

Biogen Inc. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Vumerity, its next-generation oral treatment for adults with relapsing-remitting multiple sclerosis.

The Cambridge, Mass., company said the recommendation is based on studies that compared Vumerity to its blockbuster MS drug Tecfidera to establish bioequivalent exposure of the active metabolite and relied in part on the Tecfidera's long-term safety and efficacy profile.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

Biogen said Vumerity, which has been shown to be easier on the gastrointestinal tract than Tecfidera, has become the top prescribed oral MS therapy in the U.S. since it was first approved by the U.S. Food and Drug Administration in October 2019. Tecfidera, which is approved in 69 countries, remains the most prescribed oral medication for relapsing MS in the world, Biogen said.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 17, 2021 10:02 ET (14:02 GMT)

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