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FDA Approval of Gilenya For Pediatric MS

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FDA grants Gilenya Breakthrough Designation for Pediatric MS


On December 18, 2017, the FDA granted Gilenya (fingolimod) breakthrough designation for pediatric MS based on the PARADIGMS trial results. The designation was granted to fingolimod based on phase III trial results presented at the European Committee for Treatment and Research in MS in October 2017. In the largest clinical trial yet in children and adolescents with MS, fingolimod reduced the annual number of relapses by 82% over two years, compared to treatment with interferon beta-1a (Avonex®). After two years, 86% of those on fingolimod had not experienced a relapse, compared to 39% of the Avonex group. The trial also showed benefits measured by MRI. Side effects were similar to what have been seen in the adult population.



Many thanks to all IPMSSG members who contributed to this historic result!


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