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Swiss drugmaker Novartis has received approval from the US Food and Drug Administration (FDA) for its Entresto (sacubitril/valsartan) tablets to treat heart failure with reduced ejection fraction.

Previously known as LCZ696, Entresto 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 hospitalisation.

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Entresto is an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that reduces strain on the failing heart.

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."

"Millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital."

Entresto is twice-a-day tablet that acts to enhance the protective neurohormonal systems of the heart (NP system), while simultaneously suppressing the harmful system (the RAAS).

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The approval was based on results from the 8,442-patient PARADIGM-HF study, which demonstrated significant reduction in the risk of cardiovascular death versus ACE-inhibitor enalapril.

Currently, Entresto is being reviewed by health authorities across the globe, including in Canada, Switzerland and the EU.

According to the company, Entresto is expected to achieve sales of around $5bn for the reduced ejection fraction indication, if it is approved by health authorities.

Image: Novartis AG headquarters in Basel. Photo: courtesy of Andrew.