Biogen Gets CHMP Backing for Vumerity in Multiple Sclerosis
September 17 2021 - 10:17AM
Dow Jones News
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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