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Entresto FDA Approval History

FDA Approved: Yes (First approved July 7, 2015)
Brand name: Entresto
Generic name: sacubitril and valsartan
Dosage form: Tablets
Previous Name: LCZ696
Company: Novartis Pharmaceuticals Corporation
Treatment for: Heart Failure

Entresto (sacubitril and valsartan) is a neprilysin inhibitor and angiotensin II receptor blocker combination indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
  • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

Development Timeline for Entresto

Oct  1, 2019ApprovalFDA Approves Entresto (sacubitril/valsartan) for Pediatric Heart Failure
Jul  7, 2015ApprovalFDA Approves Entresto (sacubitril/valsartan) for Heart Failure
Feb 13, 2015Novartis' Heart Failure Medicine LCZ696 Granted FDA Priority Review
Nov 17, 2014Nine New Analyses Show Novartis' LCZ696 Could Change Course of Heart Failure for Patients
Aug 30, 2014Novartis' new heart failure medicine LCZ696 cut cardiovascular deaths by 20% vs. ACE-inhibitor in landmark PARADIGM-HF trial
Aug 27, 2012New Novartis Phase II data Show LCZ696 May Provide Clinical Benefits in Patients with a Difficult-to-Treat Form of Heart Failure

Further information

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