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Novartis’ blockbuster Entresto received the US FDA approval for a broader target population

Novartis has received the US FDA approval of Entresto ((sacubitril/valsartan) for the broader target population; it is now approved for patients diagnosed with guideline-defined heart failure. The drug was approved to treat heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). The drug now indicated for patients in whom left ventricular ejection fraction (LVEF) was below normal.

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Entresto is the only and first approved product for patients with HFrEF and HFpEF.

The approval is based on PARAGON-HF, a Phase III active-controlled study in patients with guideline-defined HFpEF. In the trial, the drug is compared with valsartan alone in patients with chronic heart failure and preserved ejection fraction (HFpEF).

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The primary endpoint is novel: reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) HFHs.

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Entresto is approved in Europe and the US for treating patients with symptomatic chronic HF with reduced ejection fraction. The drug is a combination of sacubitril and valsartan; sacubitril acts on the natriuretic peptide system and valsartan act on the renin-angiotensin-aldosterone system.