Europe's drug regulator seeks stronger warnings for Gilenya after it concluded a review of the multiple-sclerosis pill, prompted by reports of heart problems and the death of a patient who took the drug.
The decision by London-based European Medicines Agency, the body responsible for licensing the pill in Europe a year ago, lifts a cloud of uncertainty from Gilenya, which Novartis touts as a potential blockbuster.
The EMA said the drug's existing warnings need to be strengthened, and said doctors shouldn't prescribe Gilenya to patients with a history of heart problems. In such cases, the patients' heart activity needs to be monitored at least overnight, the EMA said, while those starting treatment should have a heart check before and be monitored for six hours after the first dose.
Novartis will add a similar warning to the package inserts of drugs sold in the U.S., following separate discussions with the Food and Drug Administration.
