The US Food and Drug Administration has stamped its seal of approval on Amgen’s Corlanor (ivabradine), bringing millions of patients with chronic heart failure the first new treatment option in nearly 10 years.
The drug - the first in a new class of medicines - has been given the go-ahead after a priority review to reduce hospitalisation of patients with worsening CHF caused by the lower-left part of the heart failing to contract properly.
Corlanor is thought to work by decreasing the heart rate through inhibition of pacemaker cells. In a clinical trial involving more than 6,500 patients, the drug cut the relative risk of hospitalisation or cardiovascular death by 18% compared to placebo plus standard CHF medication.
On the safety side, the most common side effects emerging during the trial were too much slowing of the heart rate (bradycardia), high blood pressure, atrial fibrillation, and temporary vision disturbance (flashes of light), the FDA noted.
Corlanor is the first cardiovascular product marketed by the biotech giant. The drug was developed by French drugmaker Servier, put Amgen has rights to commercialise the drug in the US.
Its US list price has reportedly been set at $375 a month, without insurance.