New Heart Failure Rx Approved

Amgen's Corlanor (ivabradine) approved to treat heart failure by FDA

(RxWiki News) Heart failure patients may soon have a new treatment option.

The US Food and Drug Administration (FDA) Wednesday approved Corlanor (ivabradine) to treat patients with heart failure — specifically in patients whose lower-left heart does not contract well.

The Amgen drug represents a novel approval for the FDA.

“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.”

According to the FDA, around 5.1 million people in the US have heart failure. This condition occurs when the heart can't pump enough blood to the body — often the result of high blood pressure or coronary heart disease.

Corlanor withstood the test of clinical testing for safety and effectiveness. In more than 6,500 patients, Corlanor reduced the risk of rehospitalization for heart failure.

The patients in the trial did experience some side effects. These included high blood pressure, atrial fibrillation, vision disturbances and an over-slowing of the heart rate.

Review Date: 
April 16, 2015