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news.Amgen has secured approval from the US Food and Drug Administration (FDA) for Corlanor (ivabradine), an oral medication, to reduce the risk of hospitalization for worsening heart failure.
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The drug is approved for use in certain people who have chronic heart failure caused by the lower-left part of their heart not contracting well.
Corlanor 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.
Amgen Research and Development executive vice-president 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 hospitalization due to worsening heart failure in the US.
"Many heart failure patients are repeatedly admitted to the hospital, which can cause a great burden on the patient and on healthcare resources.
"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."
The drug works by blocking the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker, which regulates heart rate.
The approval is based on data from a large, multicenter, randomized, double-blind, placebo-controlled, outcomes Phase III SHIFT trial.
The safety and efficacy of Corlanor was evaluated in a clinical trial of 6,505 participants. Corlanor reduced the time to first occurrence of hospitalization for worsening heart failure compared to an inactive drug (placebo).
The Phase III trial compared Corlanor to placebo on top of standard of care (SOC) therapies, including beta blockers, in more than 6,500 clinically stable patients.
In the trial, patients received SOC, including beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blockers (ARB), diuretics and anti-aldosterone agents.