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news.The US Food and Drug Administration (FDA) has granted priority review designation for Amgen's new drug application (NDA) of its oral drug ivabradine to treat chronic heart failure (HF).
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The NDA is based on global clinical trial results from the large, multi-center, randomized, double-blind, placebo-controlled, outcomes Phase III Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT).
The trial 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 (bpm).
Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.
Amgen Research and Development executive vice-president Sean Harper said the priority review designation by the FDA is evidence that chronic heart failure is a serious condition, which leads to high rates of rehospitalization and poor prognosis despite available treatments.
Harper said: "If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition.
"We are excited about the opportunity to bring this important therapeutic option to certain patients with chronic heart failure in the U.S."
In April 2014, the company received fast track status for ivabradine from FDA to treat patients with chronic HF.