FDA Grants Sacubitril/Valsartin Expanded Indication in Chronic Heart Failure


The label also states LVEF is a variable measure and clinical judgment should be used in deciding which patients to treat.

The FDA has approved an expanded indication for sacubitril/valsartan (Entresto, Novartis) to reduce the risk of cardiovascular death and hospitalization for heart failure among adult patients with chronic heart failure. The indication states the benefits of treatment with sacubitril/valsartan 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 which patients to treat.

This is the first time that a treatment is available for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction and many with heart failure with preserved ejection fraction (HFpEF), according to a press release.

“This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced. Until now, treatment for these patients was largely empiric,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, in the press release. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

The label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only phase 2 active-controlled study to date in patients with guideline-defined HFpEF. The greatest benefit was shown in patients with LVEF below normal.

Sacubitril/valsartan is a twice-a-day prescription medicine to treat adults with long-lasting heart failure to help reduce the risk of death and hospitalization. Further, the medication may cause adverse reactions, such as swelling of the face, lips, tongue, and throat.


Novartis Entresto granted expanded indication in chronic heart failure by FDA. Novartis. https://www.multivu.com/players/English/8848351-novartis-entresto-fda-approval/. Published February 16, 2021. Accessed February 17, 2021.

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