The US label changes are the result of discussions with the FDA, following cases of heart attacks and strokes in patients who took Gilenya.
The drug is contraindicated in patients with history or presence of certain cardiac conditions, such as heart attack or stroke in the past six months, second- and third-degree atrioventricular (AV) block and other cardiac rhythm disturbances.
Novartis Pharmaceuticals head David Epstein was quoted by Pharma Times as saying that, "We welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya."
The EMA’s Committee for Medicinal Products for Human Use also recommended ECG, heart rate and blood pressure monitoring in line with the US label changes.