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FDA Approves Innovative Treatment Tysabri (Natalizumab) - Formerly Antegren - for Multiple Sclerosis: NEW YORK, NY -- November 24, 2004 -- There is new hope for the 400,000 Americans who suffer from the debilitating nervous system disease, multiple sclerosis, or MS. MS is characterized by relapses that often include symptoms such as weakness, fatigue, blurred vision, numbness and poor coordination. A promising new treatment, known as Tysabri, or natalizumab, offers physicians and their patients a new approach that specifically targets a key aspect of the inflammatory process of MS. Research suggests that Tysabri targets part of the underlying inflammatory process in MS by blocking potentially damaging immune cells from migrating from the bloodstream into the brain, where they cause inflammation and can potentially damage nerve fibers and their insulation. Tysabri was granted accelerated approval based on one-year data from two ongoing two-year trials. The first Phase III monotherapy study showed that Tysabri lead to a 66% reduction in relapses compared to placebo. A second Phase III trial looking at Tysabri added to Avonex (Interferon beta-1a), compared to Avonex alone, showed 54% relative reduction in relapses over Avonex alone. Tysabri also showed a significant effect on brain lesions as measured by MRI in both studies. Safety: Tysabri has been associated with a low risk of serious allergic reactions. SOURCE: Biogen Idec; Elan E-mail this page to a friend or colleague! To print, use this version