BioCentury
ARTICLE | Company News

EC approves Biogen Idec's Tecfidera

February 4, 2014 1:02 AM UTC

The European Commission approved an MAA from Biogen Idec Inc. (NASDAQ:BIIB) for Tecfidera dimethyl fumarate as first-line treatment for relapsing-remitting multiple sclerosis (RRMS). The company said it plans to launch the product in the EU in the "coming weeks." In November, EMA's CHMP said the drug qualifies as a new active substance (NAS), which entitles a sponsor to eight years of data exclusivity plus two years of market exclusivity starting on the date of marketing approval. The decision was a reversal of a March opinion in which the committee recommended approval of Tecfidera without the NAS designation (see BioCentury Extra, Nov. 22, 2013).

Biogen Idec launched Tecfidera in April in the U.S., where sales of the MS drug have continued to beat Street expectations. Tecfidera is also approved in Canada and Australia (see BioCentury, Jan. 13). ...