2021 | HFSA

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

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Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal[1]. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat[1].

For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)[1-3].