Biogen’s MS drug Tecfidera approved in EU

3 February 2014
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US biotech firm Biogen Idec’s (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) has been approved by the European Commission for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).

Biogen will begin to introduce Tecfidera in initial European Union countries in the coming weeks. The approval comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) determined that dimethyl fumarate qualifies as a new active substance (NAS) in November. The designation provided 10 years of regulatory exclusivity for Tecfidera in the European Union; the European launch was delayed pending a resolution to the exclusivity issue.

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