FDA Advisory Committee vote in favour of approving Entresto (sacubitril/valsartan) as a treatment of patients with heart failure with preserved ejection fraction (HFpEF)

Decision was based on data supporting Entresto in reducing worsening heart failure in PARAGON-HF trial, which also showed clinical benefit in HFpEF patients, and despite narrowly missed primary endpoint vs. valsartan, company opted to move forward with regulatory submission.

Source:

Biospace Inc.