Bethesda, MD (April 16, 2015) - The  U.S. Food and Drug Administration has approved the drug Corlanor® (ivabradine) for reducing the risk for hospitalization from worsening heart failure. Heart failure is common, but unrecognized and often misdiagnosed, affecting over 5 million Americans, Heart failure is the only major cardiovascular disorder on the rise. An estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year and the number of deaths in in the United States from this condition has more than doubled since 1979, averaging 250,000 annually.

Corlanor is the first heart failure drug to be approved in nearly ten years, and  was reviewed under the FDA’s priority review program. This process involves the expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over currently available therapy

The drug is approved for use in selected patients with chronic heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35 percent, who are in sinus rhythm with resting heart rate ≥70 beats per minute (bpm), and are also taking beta blockers at the highest dose they can tolerate.

The safety and efficacy of Corlanor was studied in a clinical trial of 6,505 participants. Corlanor was shown to reduce the time to first occurrence of hospitalization for worsening heart failure compared to placebos.

For more information and to read the official press release by Amgen, please visit here.