FDA grants expanded approval for Entresto in heart failure – Novartis

The FDA has approved an expanded indication for Entresto (sacubitril/valsartan), from Novartis, to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.

Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.

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).

This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined HFpEF. The greatest benefit was shown in patients with LVEF below normal.