FDA investigating report of rare, serious brain infection in MS patient after taking Gilenya (fingolimod)

by Charles Miller

The FDA has issued a public safety alert after a patient in Europe diagnosed with possible multiple sclerosis (MS) reportedly developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy (PML) after taking the drug Gilenya (fingolimod).

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. According to Novartis, the drug’s manufacturer, about 71,000 patients worldwide have been treated with Gilenya.

PML is a rare and serious brain infection caused by the John Cunningham virus that damages the fatty covering of the brain called myelin. PML can cause death or severe disability. The death rate has recently been reported to be about 20%. PML was first noted in patients receiving cancer chemotherapy and later in those infected with HIV.

The patient in question had been on fingolimod for nearly 8 months when PML was diagnosed, according to the Food and Drug Administration. The agency stopped short of saying fingolimod caused the condition. The FDA is working with Novartis to obtain and review all available information about the occurrence.

The FDA reports that this is the first case reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML. A series of PML cases seen with natalizumab after the drug was first approved in 2004 led to its temporary removal from the market.

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Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.