Biogen Idec has won regulatory protection for its top-selling multiple sclerosis drug Tecfidera in Europe, paving the way for its launch in markets that could account for a large proportion of future sales. The European Medicines Agency said on Friday it had granted the oral medicine a "new active substance" (NAS) designation, securing Biogen 10 years protection through data exclusivity that will stop generic firms from launching copycat versions. In March, Tecfidera was approved in the United States and also recommended for approval in Europe - but its EU launch has been delayed, pending a resolution of uncertainty over data protection. Tecfidera competes with Novartis' Gilenya and Sanofi's Aubagio, two other oral therapies for multiple sclerosis (MS).
via Health News Headlines - Yahoo! News http://news.yahoo.com/biogen-wins-protection-ms-drug-tecfidera-europe-134657162--finance.html
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