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Sunday, November 24, 2013

Biogen Idec Gets European Protection For MS Drug Tecfidera - Quick Facts

November 22, 2013

(RTTNews.com) - Biogen Idec ( BIIB ) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has determined that dimethyl fumarate in Tecfidera qualifies as a new active substance or NAS. The company noted that the designation will provide 10 years of regulatory exclusivity for Tecfidera in the European Union or EU.
The NAS determination follows a positive opinion by the CHMP in March 2013 recommending marketing authorization in the EU for Tecfidera as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis or RRMS. The CHMP's determination will now be referred to the European Commission or EC, which grants marketing authorization for medicines in the EU, the company said.

Read more: http://www.nasdaq.com/article/biogen-idec-gets-european-protection-for-ms-drug-tecfidera---quick-facts-20131122-00343#ixzz2lcR3kG2m





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