FDA alert on Gilenya safety
The US Food and Drug Administration (FDA) issued a safety alert after a European patient developed PML.
It is the first reported case and followed administration to a patient who had not previously received natalizumab (Tysabri, Biogen Idec).
Natalizumab has been associated with a higher risk of PML, a rare and serious brain infection caused by the John Cunningham virus.
Fingolimod is indicated for relapsing forms of MS and has been used by around 71,000 patients worldwide.
“Patients should not