The FDA approved ivabradine to reduce the risk of hospitalization in patients with heart failure. The agency had expedited its evaluation of the drug under its priority review program.
Ivabradine (Corlanor, Amgen) is taken orally by patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction of 35 percent or less, who are in sinus rhythm with a resting heart rate of at least 70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use. The drug blocks a channel involved in heart rate regulation and reduces spontaneous pacemaker activity, according to Amgen.
Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said that ivabradine is the first approved product in this drug class.
The FDA evaluated results from the SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study, which compared ivabradine to placebo in addition to the standard of care in 6,505 stable patients in sinus rhythm with reduced left ventricular function and a heart rate of at least 70 beats per minute who had been hospitalized for heart failure in the past 12 months. Hospital admissions for worsening heart failure occurred in 16 percent of the ivabradine group vs. 21 percent of the placebo group and heart failure-related deaths were 3 percent vs. 5 percent at a median 22.9 month follow-up.
The FDA uses the priority review process for drugs that treat a serious disease or condition and that potentially could provide a significant improvement over available therapy. Ivabradine was also granted fast track designation, which the FDA allows for drugs that may fill an unmet medical need.
Ivabradine may be available in a week, Amgen announced. It recommended a starting dose of 5 mg twice daily with meals and adjustments after two weeks, depending on heart rate. A 2.5 mg twice daily dose should be used initially for patients with a history of conduction defects and in some other patient groups.