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Friday, June 11, 2010

FDA Panel Recommends Approval of Oral Fingolimod for Relapsing MS

Jun 10, 2010

FDA Panel Recommends Approval of Oral Fingolimod for Relapsing MS -- If agency follows advice, it would become first oral disease-modifying therapy for MS

A U.S. Food and Drug Administration advisory committee today recommended that the agency approve marketing of fingolimod capsules (formerly called Gilenia, Novartis International AG) for the treatment of relapsing multiple sclerosis. If approved, fingolimod would be the first oral disease-modifying therapy for the treatment of MS. While the FDA is not required to follow the recommendations of its advisory committees, it usually does. According to Novartis, the agency is expected to make a final decision about whether to approve the drug in September 2010.

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