Entresto (previously known as LCZ696) will be provided on prescription for patients whose condition is classified NYHA class II-IV and indicated to reduce the risk of cardiovascular death and heart failure hospitalization.
The company noted that Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.
Entresto is a first in class angiotensin receptor neprilysin inhibitor (ARNI) that reduces strain on the failing heart.
The twice-a-day tablet, Entresto acts to improve the protective neurohormonal systems of the heart (NP system), while simultaneously suppressing the harmful system (the RAAS).
The approval was based on data from the 8,442-patient PARADIGM-HF trial, which showed significant reduction in the risk of cardiovascular death versus ACE-inhibitor enalapril.
Novartis Pharmaceuticals division head David Epstein said: "Despite the uncertainty and high financial risk, we designed the world’s largest heart failure trial to compare Entresto to the previous gold standard.
"As a result, millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital.
"We recognize our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week."
Currently, Entresto is being reviewed by health authorities across the world, including in Canada, Switzerland and the EU.