Tag Archives: PARAGON-HF

Novartis Wins with Entresto PARAGON-HF FDA Approval

Novartis announced FDA has approved the Entresto sNDA based on results from the PARAGON-HF CVOT (view updated label here). For context, the new indication eliminates the qualifier of HFrEF; however, an additional statement is included, stating the benefit is most clearly evident in patients with LVEF below normal. While the updated label does not include a pure HFpEF indication, it is thought to represent the best-case scenario for Novartis. Below, FENIX provides thoughts on the new Entresto HF indication as well as implications to the evolving HF market, notably Lexicon’s sotagliflozin.

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UPDATED – Entresto HFpEF Adcom: 12-1 Positive Vote, but End Result Remains Confusing

Content now updated with the Q1 2021 PDUFA date announced in the post-adcom Novartis press release.

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Entresto HFpEF Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming Entresto HFpEF FDA advisory committee meeting on December 15, 2020 (view materials here). As previously stated by FENIX, the outcome of the Entresto adcom is believed to have broad ripple effects throughout the CV/Met market. Below, FENIX provides a brief overview of the key points FDA will consider as well as preliminary thoughts on the adcom.

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