New FDA warning on Gilenya and PML

5 August 2015

The US Food and Drug Administration yesterday issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).

These are the first cases of PML reported in patients taking Gilenya, developed and marketed by Swiss pharma giant Novartis (NOVN: VX), who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label, the FDA said.

In an August 2013 Drug Safety Communication, the FDA reported that a patient developed PML after taking Gilenya (The Pharma letter August 30, 2013). PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

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