Amgen's Corlanor® is the first CHF medicine to be approved by the FDA in nearly a decade

WASHINGTON - April 16, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved Amgen’s Corlanor^® (ivabradine) to treat chronic heart failure. The medication is orally administered and is indicated to reduce the risk of hospitalization for worsening heart failure in 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 either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.

"We are excited to introduce Corlanor, the first new chronic heart failure medicine approved by the FDA in nearly a decade, for patients who are at a significantly greater risk of hospitalization due to worsening heart failure in the U.S.," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Many heart failure patients are repeatedly admitted to the hospital, which can cause a great burden on the patient and on healthcare resources. We hope that today's approval of Corlanor as an innovative therapeutic option will address a major unmet need for patients, their families and the healthcare system."

Approval was granted based on global clinical trial data collected from the the Phase 3 SHIFT study (Systolic Heart failure treatment with the If inhibitor ivabradine Trial). Corlanor was compared to placebo on top of standard of care (SOC) therapies in 6,500 patients. These patients were hospitalized for heart failure in the past 12 months and in sinus rhythm with reduced left ventricular function (LVEF ≤35 percent) and heart rate ≥70 bpm. Results indicated Corlanor reduced the risk of hospitalization or cardiovascular death for worsening heart failure, with 18 percent relative risk reduction (RRR) versus placebo.

“The approval of Corlanor is an important step forward for the treatment of patients with chronic heart failure in the U.S. Because its mechanism of action is unique, it will complement the use of standard heart failure therapies, including beta blockers," said Jeffrey S. Borer, M.D., professor of Medicine, Cell Biology, Radiology and Surgery, and chief of Cardiovascular Medicine at State University of New York, Downstate Medical Center. "Despite beta blockade and other therapies, many people with chronic heart failure continue to suffer hospitalizations due to worsening heart failure. For these patients, when heart rate is greater than or equal to 70 bpm, Corlanor may be an appropriate treatment option and can be expected to add benefit."

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