FDA Grants ‘Priority Review’ Designation for Ivabradine for Treatment of Chronic Heart Failure
Drug approved in Europe in 2012
The FDA has granted “priority review” status for ivabradine (Amgen) for the treatment of chronic heart failure.
Ivabradine is an oral drug that inhibits the If (“funny”) current in the sinoatrial node — the body’s cardiac pacemaker. The drug works to slow the heart rate without having negative effects on myocardial contractility or ventricular repolarization.
Heart failure is a common condition that affects approximately 26 million people worldwide, including approximately 5.1 million people in the U.S.
The new drug application (NDA) for ivabradine was based on global clinical trial data from the pivotal phase III Systolic Heart Failure Treatment With the If Inhibitor Ivabradine Trial (SHIFT), a randomized, double-blind, placebo-controlled outcomes study. In this investigation, ivabradine was compared with 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 a heart rate of ≥ 70 beats per minute.
The FDA assigns a “priority review” designation to applications for drugs that treat serious conditions and that would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared with available therapies. Such a designation sets a goal date for taking action on an application within 6 months of receipt.
In addition, in April 2014, the FDA granted a “fast track” designation for ivabradine for the treatment of patients with chronic heart failure. This designation is intended to facilitate the development and review of drugs that treat serious conditions and that fill an unmet medical need.
Heart failure is the leading cause of re-hospitalization in Medicare beneficiaries over the age of 55, and approximately 50% of people with the disorder in the U.S. die within 5 years of diagnosis. Projections have shown that by 2030, the prevalence of heart failure will increase 25% from 2013 estimates. Despite the broad use of standard treatments, the prognosis for heart failure is poor.
Ivabradine was approved in Europe in 2012 under the trade name Procoralan for the treatment of chronic heart failure in patients with elevated heart rates.
Source: Amgen; August 27, 2014.