April 16, 2015 — The U.S. Food and Drug Administration (FDA) approved Amgen’s ivabradine (Corlanor) to reduce hospitalization from worsening heart failure.
Ivabradine is approved for use in certain people who have chronic heart failure caused by the ventricles contracting inefficiently. The drug 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.
Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart cannot pump enough blood to meet the body's needs. Heart failure develops over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as coronary heart disease and high blood pressure.
“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.”
Ivabradine was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. It was also granted fast track designation, which helps facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. For products that have been designated as fast track, FDA may review portions of a marketing application on a rolling basis.
The safety and efficacy of ivabradine was studied in a clinical trial of 6,505 participants. The drug reduced the time to first occurrence of hospitalization for worsening heart failure compared to placebo.
The most common side effects observed in clinical trial participants were too much slowing of the heart rate (bradycardia), hypertension, atrial fibrillation and temporary vision disturbance (flashes of light).
Ivabradine will be dispensed with a patient medication guide that provides instructions for its use and important drug safety information. The FDA said healthcare professionals should counsel patients about the risk of harm to an unborn baby, and women should not become pregnant while taking ivabradine.
Patients should alert their healthcare professional if they experience symptoms of an irregular heartbeat, feel that the heart is pounding or racing, have chest pressure, or worsened shortness of breath. Low heart rate is a common side effect of ivabradine and can be serious. Patients should tell their health care professional if they have symptoms such as dizziness, weakness or fatigue.
For more information: www.amgen.com