FDA Approves Novartis’ Heart Failure Drug

The US Food and Drug Administration has approved Novartis’ Entresto (sacubitril/valsartan) for treating heart failure with reduced ejection fraction. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

Novartis has high hopes for Entresto, pegging it as one of the key drugs among its new product candidates. A recent Thomson Reuters analysis estimates 2019 sales for Entresto at $3.7 billion, and Novartis estimates offer possible peak sales in excess of $5 billion for the reduced ejection fraction indication on global basis.

Entresto is currently undergoing review by health authorities around the world, including in Canada, Switzerland, and the European Union, where it is under accelerated review.

Entresto is an angiotensin receptor neprilysin inhibitor that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system, the renin-angiotensin-aldosterone system (RAAS).

Source: Novartis and FDA

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