NAPSR News: FDA Grants Amgen Priority Review For Ivabradine To Treat Chronic Heart Failure

WASHINGTON - Aug. 28, 2014 - PRLog -- Amgen has received a priority review designation from the U.S. Food and Drug Administration (FDA) for ivabradine for the treatment of chronic heart failure (HF).  Ivabradine is an investigational oral drug inhibiting the sinoatrial node(cardiac pacemaker) and slows the heart rate without negative effects on myocardial contractility or ventricular repolarization.

"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. If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are excited about the opportunity to bring this important therapeutic option to certain patients with chronic heart failure in the U.S."

The priority review designation is normally allocated to drug applications to treat serious conditions and pending regulatory approval, improve safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.  The priority review  for ivabradine was based on clinical trial data achieved from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study assessing 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate >70 beats per minute (bpm). The FDA also granted fast track designation for ivabradine for patients with chronic HF in April 2014. This designation is intended to accelerate the developmental and review process for drugs to treat serious conditions.

Heart failure affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S. An estimated 50 percent of people diagnosed die within five years and it is projected that by 2030 HF will increase by 25 percent.

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