FDA Approves Amgen's Heart Failure Drug Corlanor

The U.S. Food and Drug Administration said Wednesday that it has approved Amgen, Inc.'s (AMGN) Corlanor to reduce hospitalization from worsening heart failure.

Corlanor is approved for use in certain people who have chronic heart failure caused by the lower-left part of their heart not contracting well. 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.

"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 Harper, executive vice president of Research and Development at Amgen.

The safety and efficacy of Corlanor was studied in a clinical trial of 6,505 participants. Corlanor reduced the time to first occurrence of hospitalization for worsening heart failure compared to placebo. Corlanor was reviewed under the FDA's priority review program.

Heart failure is a common condition that affects about 5.1 million people in the United States. The leading causes of heart failure are diseases that damage the heart, such as coronary heart disease and high blood pressure.

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