A web-blog (formerly known as Stu's Views and MS News), now published by MS Views and News, a patient advocacy organization. The information on this blog helps to Empower those affected by Multiple Sclerosis globally, with education, information, news and community resources.
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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.