Approval given to market Tysabri in Europe

The European Commission gave approval on June 29, 2006 for Biogen Idec and Elan Corporation to begin marketing Tysabri® (natalizumab) as a treatment for relapsing remitting multiple sclerosis to delay the progression of disability and reduce the frequency of relapses.

The approval was based on a submission that included Tysabri two-year Phase III 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 and minimize the potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

This action follows a recommendation made by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which on April 28, 2006, issued a positive opinion recommending marketing authorisation for Tysabri.