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For the first time in a decade, the FDA has approved a drug for heart failure -- ivabradine (Corlanor).
The drug, marketed in the U.S. by Amgen, is approved to "reduce hospitalization from worsening heart failure." The drug was developed by Les Laboratoires Servier and is approved in Europe for treatment of angina and for chronic heart failure with elevated heart rates.
The FDA said 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."
Ivabradine has been studied for several years, and in 2014 a pivotal trial of it was considered one of the potentially practice-changing findings presented at that year's American College of Cardiology meeting.
In August 2014, the drug received priority review designation from the FDA. That program permits expedited review of drugs "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.
The FDA based its approval decision on a review of ivabradine safety and efficacy, primarily in a trial of 6,505 participants.
The most common side effects observed in that study were bradycardia, hypertension, atrial fibrillation, and temporary vision disturbances.
A patient Medication Guide will be included with the product, providing instructions for its use, and important drug safety information will be dispensed with the drug, which is contraindicated in pregnant women.
From the American Heart Association: