Biogen Says Tecfidera Approved in China to Treat Relapsing Multiple Sclerosis
By Stephen Nakrosis
Biogen Inc. on Thursday said its Tecfidera received approval
from China's National Medical Products Administration for the
treatment of relapsing multiple sclerosis.
The company said Tecfidera, or dimethyl fumarate, "was approved
under the National Medical Products Administration priority review
process evaluating therapies with urgent clinical needs."
The company said the approval was based on data from "the
global, pivotal Phase 3 DEFINE and CONFIRM studies, which enrolled
more than 2,600 patients."
Biogen said Tecfidera was introduced in 2013 and has been used
to treat more than 500,000 individuals with MS worldwide.
--Write to Stephen Nakrosis at firstname.lastname@example.org
(END) Dow Jones Newswires
April 15, 2021 17:37 ET (21:37 GMT)
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