Novartis Wins with Entresto PARAGON-HF FDA Approval
Here is a brief preview of this blast: 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.