FDA approves ivabradine for treatment of HF

The FDA has approved ivabradine to reduce hospitalization from worsening HF, according to a press release.

Ivabradine (Corlanor, Amgen) is indicated for stable patients with symptomatic HF, a normal heartbeat with a resting heart rate of at least 70 bpm and those taking maximally tolerated doses of beta-blockers.

Ivabradine was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. The drug was also granted fast track designation, according to the release.

“Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class,” Norman Stockbridge, MD, PhD,director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, stated in the release.

The efficacy and safety of ivabradine was studied in a clinical trial of 6,505 participants. Results demonstrated that ivabradine reduced the time to first occurrence of hospitalization for worsening HF compared with placebo. The most common adverse effects associated with ivabradine were bradycardia, hypertension, atrial fibrillation and temporary vision disturbance, according to the release.

The drug will be dispensed with a patient medication guide that provides instructions for use and important drug safety information. Health care professionals should counsel patients about the risk for harm to an unborn baby and women should not become pregnant while taking ivabradine, according to the release.

Disclosure: Stockbridge is director of the division of cardiovascular and renal products at the FDA.

Source: www.healio.com