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.

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