FDA has issued issued a safety alert after a patient with multiple sclerosis (MS) in Europe developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy (PML) following treatment with Gilenya (fingolimod). According to the agency, this is the first case of PML in a patient taking Gilenya who had not previously received Tysabri (natalizumab, marketed by Biogen Idec), which is an MS drug associated with a higher risk of PML.
FDA warns patients not to stop taking Gilenya without consulting their doctors. FDA is working with Novartis to investigate this case and will review all available information about this occurrence. The final conclusions and recommendations will be announced after completion of the evaluation.
Gilenya was approved in 2010 as the first oral treatment for relapsing forms of MS and approximately 71,000 patients worldwide have been treated since its launch, according to Novartis. Novartis first reported this new case of PML in July.