FDA Approves Corlanor® (ivabradine) to Reduce the Risk of Hospitalization for Worsening Heart Failure in Patients With Chronic Heart Failure
Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Corlanor® (ivabradine), an oral medication indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35 percent, who are in sinus rhythm with resting heart rate ≥70 beats per minute (bpm) and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.
Corlanor is contraindicated in patients with acute decompensated heart failure, blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial block, 3rd degree AV block (unless a functioning demand pacemaker is present), a resting heart rate < 60 bpm prior to treatment, severe hepatic impairment, pacemaker dependence (heart rate imposed exclusively by the pacemaker) and concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors.
- Corlanor is the first new chronic heart failure medicine approved by the FDA in nearly a decade.
- Heart failure is a common condition that affects approximately 5.7 million people in the U.S., about half of which have reduced left ventricular function.1,2
- Despite broad use of standard treatments, the prognosis for patients with heart failure is poor.3 Projections show that by 2030, the prevalence of heart failure will increase 46 percent from 2012 estimates.1
Read the press release for additional information.
View the full prescribing information and medication guide.
1. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics – 2015 update: a report from the American Heart Association. Circulation. 2015;131:e29-e332.
2. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCP/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327.
3. Swedberg K, Komajda M, Bohm M, et al. Ivabradine and Outcomes in Chronic Heart failure (SHIFT): a Randomised Placebo Controlled Study. Lancet. 2010; 376:875-85.