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Entresto: FDA has expanded indication in chronic heart failure with preserved ejection fraction


The FDA ( 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.

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.

Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing protective neurohormonal systems ( i.e., natriuretic peptide system ) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system ( RAAS ).
Other common medicines for heart failure, called angiotensin converting enzyme inhibitors ( ACEi ) and angiotensin II receptor blockers ( ARBs ), only block the harmful effects of the overactive RAAS.
Entresto contains the neprilysin inhibitor Sacubitril and the angiotensin receptor blocker Valsartan.

Approximately 6 million Americans are living with chronic heart failure ( CHF ). Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal.
The prevalence of heart failure is increasing as the population ages. Patients often face worsening symptoms that result in frequent hospitalizations for heart failure.
Each hospitalization event is associated with worsening long-term prognosis. Approximately one in four patients are re-admitted for heart failure and 10% may die within 30 days of discharge.
Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a diagnosis of heart failure. ( Xagena )

Source: Novartis, 2021

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