Important expanded FDA indication for Novartis' Entresto

The US Food and Drug Administration 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 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,, says the drug’s maker Novartis (NOVN: VX).

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).