Resounding FDA AdCom backing for use of Entresto to treat patients with HFpEF

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 12 to 1 that the data presented support the use of Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF), the drug’s developer, Swiss pharma giant Novartis (NOVN: VX), announced late yesterday.

This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, an especially hard to treat form of HF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).

HFpEF indication could double Entresto sales