US regulators have green-lighted Novartis’ hotly-anticipated heart failure drug Entresto (formerly LCZ696) six weeks ahead of schedule, offering patients a new option which many hope could revolutionise treatment of the condition.

A twice daily pill, Entresto (sacubitril/valsartan) has a unique mode of action thought to reduce the strain on the failing heart by enhancing its protective neurohormonal systems while simultaneously suppressing the harmful ‘RAAS’ one. 

The drug is the first treatment shown to have a significant mortality benefit over an ACE-inhibitor; data presented at the European Society of Cardiology meeting in Barcelona last August showed that it cut cardiovascular deaths by 20% versus enalapril.

At the time, Milton Packer, co-primary author of the study from University of Texas Southwestern Medical Center in Dallas, said if the drug wins approval “it would be difficult to understand why physicians would continue to use traditional ACE inhibitors or angiotensin receptor blockers for the treatment of heart failure”.

Entresto will now be available on prescription in the US for heart failure with reduced ejection fraction in patients whose condition is classified NYHA class II-IV, indicated to cut the risk of cardiovascular death and heart failure hospitalisation. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

Nearly six million people live with heart failure in the US, and about half have the reduced ejection fraction form. But despite current therapies, up to 50% of patients die within five years of diagnosis, highlighting the scope for improving treatment outcomes.