FDA to add PML cases to Gilenya label

FDA plans to update the label of multiple sclerosis (MS) drug Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN) to include one definite case and one probable case of progressive multifocal leukoencephalopathy (PML) reported in Gilenya-treated patients. The agency said these are the first reported cases of PML in MS patients receiving Gilenya who had not been previously treated with an immunosuppressant drug.

In August 2013, FDA investigated a case of PML reported in a patient treated with Gilenya. The case was not "conclusively linked" to Gilenya because the patient had been treated with an immunosuppressant drug prior to receiving Gilenya, as well as repeated courses of high-dose corticosteroids over the course of the disease (see BioCentury Extra, Aug. 29, 2013). ...