Gilenya fingolimod regulatory update

EMA and FDA updated the label for Gilenya fingolimod from Novartis to include cardiovascular-related warnings and recommendations for initiating treatment with the multiple sclerosis drug. Following a safety review in which EMA's CHMP concluded that Gilenya has a positive benefit-risk profile, the agency said physicians should not prescribe the drug to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. When Gilenya is considered necessary in these patients, CHMP said heart rate activity should be monitored at least overnight following the first dose and physicians should seek advice from a cardiologist on appropriate monitoring. FDA also said patients with pre-existing cardiac conditions or taking concomitant anti-arrhythmic drugs who initiate treatment with Gilenya require overnight monitoring.

Additionally, both updated labels state that all patients should be administered an ECG and a blood pressure measurement before starting Gilenya. Patients should also have their blood pressure and heart rate checked every hour for 6 hours after the first dose. CHMP also said monitoring should be extended for at least 2 hours in patients whose heart rate is lowest 6 hours after receiving the first dose, and said patients who develop clinically significant heart problems should continue to be monitored over night or until the problems have resolved. ...