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

(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.

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