With details of the PARAGON-HF trial of Entresto (sacubitril/valsartan) in heart failure with preserved ejection fraction (HFpEF) unveiled at the European Society of Cardiology Congress in Paris, Novartis AG is optimistic that it will still be able to extend its reach at least some way into this large and untapped space. Despite missing the endpoint of the pivotal trial, the company believes it has good enough data to pursue approval for subsets of patients, and the presentation by the trial’s executive committee co-chair Scott Solomon of the Brigham and Women’s Hospital and Harvard medical School in Paris elucidated those subgroups for the first time.
PARAGON-HF: Novartis Hangs Onto Hope For Entresto In HFpEF
Despite Phase III miss, Novartis is hopeful that the totality of the evidence will secure it at least a limited label expansion to a sizable but harder to treat portion of the heart failure market than Entresto already serves.
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