Corlanor from Amgen granted FDA approval

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced approval for Corlanor (ivabradine) for use in certain patients who have chronic heart failure. 

 

According to the FDA, heart failure is a common condition that affects close to 5.1 million people in the United States. The condition arises when the heart cannot pump enough blood to meet the body’s needs. Heart failure worsens over time as the organ’s pumping action grows weaker. Coronary heart disease and high blood pressure are leading causes of heart failure, the FDA said.

 

“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge, M.D., Ph.D., 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.”

 

Corlanor was granted priority review by the FDA, which expedites the review process for drugs that are indicated to treat serious disease and conditions and may provide significant improvements over therapies that are currently available. The drug is produced by Amgen.