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.

Novartis itself alerted the FDA that a patient who had been treated with Gilenya has developed PML. However, according to Novartis at the time, it did not believe that Gilenya was the cause behind this patient in the UK developing PML.