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FDA Approves Fingolimod as First-Line Treatment for Relapsing Forms of MS NEW YORK -- September 22, 2010 -- The US Food and Drug Administration (FDA) has approved fingolimod 0.5 mg (Gilenya) as first-line treatment for relapsing forms of multiple sclerosis. Fingolimod reduces the frequency of MS relapses and helps slow the build-up of some of the physical problems caused by MS. In clinical trials, fingolimod has a well-studied safety and tolerability profile, which has been characterised in over 2,600 patients in clinical trials, some of whom are in their seventh year of treatment, with more than 4,500 patient years of experience. The approval was based on the largest clinical trial program ever submitted to date to the FDA for the MS drug and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI). SOURCE: Novartis E-mail this page to a friend or colleague! To print, use this version