FDA reveals new Gilenya PML probe; Novartis says link 'unlikely'
This article was originally published in Scrip
Executive Summary
The US FDA on 29 August said it had initiated an investigation into a report of progressive multifocal leukoencephalopathy (PML) in a patient who had taken Novartis' oral multiple sclerosis drug Gilenya (fingolimod) – the first such case of the rare, serious brain infection in a person on the medicine who had not previously been treated with Biogen Idec's Tysabri (natalizumab).