FDA investigating rare brain infection in patient taking Gilenya

In a safety communication issued on Thursday (August 29), the US Food and Drug Administration is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod), from Swiss drug major Novartis (NOVN: VX).

This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug from US biotech firm Biogen Idec (Nasdaq: BIIB) associated with a higher risk of PML.