Entresto FDA Approval History
Last updated by Judith Stewart, BPharm on April 15, 2024.
FDA Approved: Yes (First approved July 7, 2015)
Brand name: Entresto
Generic name: sacubitril and valsartan
Dosage form: Tablets and Sprinkle Capsules
Company: Novartis Pharmaceuticals Corporation
Treatment for: Heart Failure
Entresto (sacubitril and valsartan) is a neprilysin inhibitor and angiotensin II receptor blocker combination used in the treatment of heart failure.
- Entresto is indicated:
- 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.
- for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.
Development timeline for Entresto
Further information
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