The US Food and Drug Administration has given the green light to Amgen’s Corlanor (ivabradine), making it the first new treatment for chronic heart failure to be approved across the pond in nearly a decade.
The therapy, which is thought to work by decreasing heart rate through inhibition of pacemaker cells, has been given the go-ahead after a priority review by the FDA. The approval is based on a clinical trial involving more than 6,500 patients.
In the study, Corlanor cut the relative risk of hospitalisation or cardiovascular death by 18% compared to placebo plus standard CHF medication. It is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.
The most common side effects seen in the trial were too much slowing of the heart rate (bradycardia), high blood pressure, atrial fibrillation and temporary vision disturbance (flashes of light).
Ivabradine is already approved in Europe under the brand name Procoralan for stable angina and CHF. Amgen got US rights to sell the pill through a cross-licensing pact signed with developer Servier in 2013.