Amgen has received approval from the US Food and Drug Administration (FDA) for its Corlanor (ivabradine) to treat patients with chronic heart failure.
Corlanor is an oral medication indicated to reduce the risk of hospitalisation for worsening heart failure in patients with stable and symptomatic chronic heart failure with left ventricular ejection fraction (LVEF).
Developed by Les Laboratoires Servier, Amgen holds rights to commercialise Corlanor in the US, through collaboration with Servier.
Amgen research and development executive vice-president Dr Sean Harper said: "We are excited to introduce Corlanor, the first new chronic heart failure medicine approved by the FDA in nearly a decade, for patients who are at a significantly greater risk of hospitalisation due to worsening heart failure in the US.
"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 healthcare system."
Corlanor is said to block hyperpolarisation-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker that regulates heart rate.
It will reduce the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If-current to slow the heart-rate with no effect on ventricular repolarisation and no impact on myocardial contractility.
Approval was based on global clinical trial data, including a large, multi-centre, randomised, double-blind, placebo-controlled and outcomes trial.
The Phase III Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) compared Corlanor against placebo on top of standard of care (SOC) therapies, including beta blockers in around 6,500 clinically stable patients.
According to the company, Phase III SHIFT study demonstrated that Corlanor significantly reduced the risk of primary composite endpoint of hospitalisation or cardiovascular death for worsening heart failure.
Image: Amgen headquarters in Thousand Oaks, California, US. Photo: courtesy of Coolcaesar.