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Novartis’ heart failure med Entresto scores an expanded approval in the US

February 17, 2021


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.

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