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
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