Amgen announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current (“funny” current) in the sinoatrial node, the body’s cardiac pacemaker. Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization. Heart failure is a common condition that affects approximately 26 million worldwide, including approximately 5.1 million people in the United States.
“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 Harper, 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 United States.”
The New Drug Application (NDA) 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 pivotal 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 (bpm).
Priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies. A priority review designation will set a goal date for taking action on an application within six months of receipt.
In addition, in April 2014, the FDA granted fast track designation for ivabradine for patients with chronic HF. A fast track designation is a process intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Products that have been designated as fast track can submit portions of a marketing application before submitting the complete application, known as rolling review.
Heart failure is the leading cause of rehospitalization in Medicare beneficiaries over age 55, and approximately 50 percent of people diagnosed with HF in the U.S. die within five years of diagnosis. Projections show that by 2030, the prevalence of HF will increase 25 percent from 2013 estimates. Despite broad use of standard treatments, the prognosis for HF is poor.
Date: August 27, 2014