The new FDA approval has indicated Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure.
The new indication approval is based on evidence from Novartis’ PARAGON-HF trial – a Phase III study in patients with guide-line defined heart failure with preserved ejection fraction (HFpEF).
According to Novartis, the greatest benefit from Entresto treatment was shown in patients with left ventricular ejection fraction (LVEF) below normal.