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Monday, September 2, 2013
FDA Alert for Multiple Sclerosis Drug
02 September 2013
By Richard Lenti
The Food and Drug Administration has issued an alert concerning the multiple sclerosis drug fingolimod, after a patient in Europe developed a rare and serious brain infection while taking the medication. Fingolimod is sold under the brand name Gilenya by Novartis (NYSE:NVS).
The agency says that this is the first reported case of the disease progressive multifocal leukoencephalopathy (PML) in a patient receiving Gilenya, who had not previously been on Tysabri (natalizumab), an intravenous MS drug previously associated with a higher risk of PML.