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Novartis : FDA Panel Recommends Entresto To Treat Patients With HFpEF

Novartis (NVS) said Tuesday that the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction or HfpEF.

The committee's positive decision was based on data supporting the benefit of Entresto in reducing worsening heart failure in patients studied in PARAGON-HF.

If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction or HfrEF.

The FDA is expected to make a decision on the supplemental New Drug Application or sNDA in the first quarter of 2021.

Entresto is approved in 115 countries worldwide for the treatment of HFrEF, with more than 2.6 million patient-years of exposure to date.

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