FDA Approves New Chronic Heart Failure Medicine
Today's approval of Amgen's ivabradine makes it the first new chronic heart failure medicine that has been approved by the FDA in almost a decade.
Today’s approval of Amgen’s ivabradine (Corlanor) makes it the first new chronic heart failure medicine that has been approved by the FDA in almost a decade.
Corlanor aims to reduce the risk of hospitalization for worsening heart failure among patients with stable, symptomatic heart failure with left ventricular ejection fraction ≤35%, who are in sinus rhythm with resting heart rate ≥70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use, according to the FDA.
A study compared Corlanor versus placebo, in addition to standard of care therapies, including beta blockers, in more than 6500 patients. Results of the study demonstrated that Corlanor significantly reduced the risk of hospitalization or cardiovascular death for worsening heart failure compared with placebo.
Adverse side effects may include bradycardia, hypertension, atrial fibrillation, and visual brightness.
According to the FDA, the recommended dose is a 5 mg tablet twice daily with meals, but the dose should be reassessed after 2 weeks depending on the patient’s heart rate. Those with a history of conduction defects may want to start treatment at half the recommended dosage and can increase the dose based on their heart rate from there.
Patients should have access to the heart failure medicine in about 1 week.
“Many heart failure patients are repeatedly admitted to the hospital, which can cause a great burden on the patient and on health care resources,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “We hope that today’s approval of Corlanor as an innovative therapeutic option will address a major unmet need for patients, their families, and the health care system.”