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Entresto 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 death and hospitalization in patients with chronic heart failure.

FDA Approval: The approval of Entresto was based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death and hospitalizations related to heart failure versus ACE-inhibitor enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Mechanism: Entresto contains a combination of sacubitril, a first-in-class neprilysin inhibitor, and valsartan, an angiotensin II antagonist already FDA approved as Diovan. It works by reducing the strain on the failing heart.

Administration: Entresto tablets are taken twice daily, usually in conjunction with other heart failure medicines.

Side Effects: Common side effects observed in clinical trial participants being treated with Entresto were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment).

Additional Information: Angioedema has been reported as a serious side effect of Entresto, and patients are advised to seek emergency medical assistance if they experience symptoms such as trouble breathing.

Development History and FDA Approval Process for Entresto

DateArticle
Jul  7, 2015Approval FDA 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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