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Wednesday, December 16, 2020

FDA advisory panel backs use of Novartis' Entresto in heart failure

 

  • The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 12 to 1 supporting the use of Novartis' (NYSE:NVS) Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF).
  • This was based on data supporting the benefit of Entresto in reducing worsening heart failure in patients studied in PARAGON-HF.
  • If approved, Entresto could become the first therapy as well as mediation approved for heart failure.
  • The FDA decision on the sNDA is expected in Q1 2021.
  • https://seekingalpha.com/news/3644765-fda-advisory-committee-backs-use-of-novartis-entresto-in-heart-failue

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