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Biogen, Elan receive EU approval for Tysabri in treatment of multiple sclerosis
By Lisa Kerner
Charlotte, N.C., June 29 - Biogen Idec and Elan Corp. received approval from the European Commission to market Tysabri (natalizumab) as a treatment for relapsing remitting multiple sclerosis (MS).
The approval was based on Tysabri two-year phase 3 clinical trial data, findings from the comprehensive safety evaluation, suggested labeling, and a risk management plan designed to inform physicians and patients of the benefits and risks of Tysabri treatment.
"Today marks an important step forward for the European MS patient community," Biogen chief executive officer James C. Mullen said in a company news release.
"Tysabri represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice."
Cambridge, Mass.-based Biogen develops novel therapies for oncology, neurology and immunology.
Elan is a neuroscience-based biotechnology company located in Dublin, Ireland.
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