The US Food and Drug Administration (FDA) is continuing to investigate a potential link between Novartis's multiple sclerosis (MS) drug Gilenya (fingolimod) and a single case of a rare and serious brain infection in a European patient.
The US Food and Drug Administration (FDA) is continuing to investigate a potential link between Novartis’s multiple sclerosis (MS) drug Gilenya (fingolimod) and a single case of a rare brain infection in a European patient.
According to the FDA, the patient had been taking fingolimod for nearly 8 months before being diagnosed with progressive multifocal leukoencephalopathy (PML), a brain infection that damages myelin and usually causes death or severe disability. The FDA first announced that it was investigating the case in August 2013.
This is the first case of PML to be reported in patient who hadn’t previously received Tysabri (natalizumab), which has previously been linked to a higher risk of the serious brain infection. Novartis has stated that its review of all available evidence shows that it’s unlikely that the PML case is associated with fingolimod, which has been FDA-approved for relapsing MS since 2010.
The FDA has notified patients that they shouldn’t discontinue the drug without discussing the issue with their physician first.