LONDON (Reuters) - Experts at the European Medicines Agency have recommended measures to reduce the risks associated with a drug from private French company Servier that helps lower the heart rate and which was licensed to U.S. group Amgen last year.
Ivabradine is not currently approved in the United States but it is sold in Europe for treating stable angina, or chest pain due to obstruction of heart arteries, and for heart failure, when the heart fails to pump blood effectively.
The EU agency’s Pharmacovigilance Risk Assessment Committee said its new recommendations were aimed at reducing the risk of heart problems, including heart attack and excessively low heart rate, in patients taking the medicine.
The measures include checking the resting heart rate of patients before treatment and monitoring them for atrial fibrillation, or irregular heartbeat.
The proposals, which must be forwarded to a second committee at the agency before being adopted, follow results from a major clinical study that found a large group of patients with severe activity-limiting angina did worse on the drug.
The agency first announced in May it was reviewing the safety of ivabradine. Servier said at the time it had informed all relevant regulators about the study findings and would update doctors as soon as the European agency made a decision.
Amgen signed a deal in July 2013 for U.S. commercial rights to the drug.
Reporting by Ben Hirschler