FDA approves Corlanor to treat heart failure

FDA has approved ivabradine (Corlanor, Amgen) to reduce hospitalization due to worsening heart failure.

Heart failure is a condition affecting over 5 million people in the United States and is characterized by fatigue, shortness of breath and congestion related to inadequate tissue perfusion and fluid retention. Heart failure develops overtime as the heart loses its ability to pump due to myocardial injury. The leading causes of heart failure include cardiovascular diseases, such as coronary heart disease and hypertension.

Related: Study: Too many heart failure patients are treated with IV fluids

Corlanor is an antianginal agent approved for use in patients who have chronic heart failure caused by the lower-left part of the heart not contracting well. It is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.

Related: More FDA drug approvals

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

The safety and efficacy of Corlanor were assessed in a clinical trial of 6,505 participants. Results showed that Corlanor reduced the time to first occurrence of hospitalization of hospitalization for worsening heart failure compared to an inactive drug. The most common side effects observed in the clinical trial included bradycardia, hypertension, atrial fibrillation, and temporary vision disturbances. Corlanor is to be dispensed along with a patient Medication Guide to provide information about its use and important safety important.

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