FDA Approves Ivabradine (Corlanor) for Chronic HF

Disclosures

April 15, 2015

SILVER SPRING, MD — A drug already available in Europe has been approved by the US Food and Drug Administration for reducing the risk for hospitalization from worsening heart failure[1]. The agent, ivabradine (Corlanor, Amgen), is indicated for stable patients with heart failure and a heart rate of >70 per minute on maximally tolerated beta-blockers, the agency announced today.

The approval is based on the international, placebo-controlled SHIFT trial, published in 2010, which randomized >6500 patients in New York Heart Association class II-IV heart failure and left ventricular ejection fraction ≤35%. The trial saw a highly significant 18% drop in risk for cardiovascular death or hospitalization for worsening heart failure over an average of 23 months in patients treated with ivabradine, as covered at the time by heartwire from Medscape.

Ivabradine was shown to offer no special clinical benefit to patients with stable coronary artery disease in the large randomized SIGNIFY trial. The drug is available in Europe for angina and heart failure under the names Corlentor and Procoralan (Servier).

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