Amgen announced that the Food and Drug Administration (FDA) has granted Priority Review to its New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral drug that inhibits the “funny” current in the sinoatrial node, the body’s cardiac pacemaker thus slowing the heart rate without negative effects on myocardial contractility or ventricular repolarization.
The NDA submission is based on global clinical trial data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study, a large, multi-center, randomized, double-blind, placebo-controlled, outcomes trial. The SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate >70 beats per minute.
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In April 2014, the FDA granted Fast Track designation for ivabradine for patients with chronic heart failure.
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