PARAGON-HF: Novartis Hangs Onto Hope For Entresto In HFpEF

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. 

Entresto, an angiotensin receptor-neprilysin inhibitor, was approved for heart failure with reduced ejection fraction (HFrEF) in the US and EU in 2015. In the first half of 2019 its sales grew by 77% to $778m. Novartis has been investigating its use also in HFpEF, a similarly sized patient population with no approved therapy which offers the promise of significant revenue expansion