Recommendation from FDA Advisory Committee for use of ARNI in HFpEF

A positive decision was made by the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) with 12 to 1 votes for recommendation of use of sacubitril/valsartan in treatment of patients with HFpEF. This decision was based on data demonstrating benefit of sacubrtril/valsartan in reducing worsening HF (total HF hospitalizations and urgent HF visits) in patients in the PARAGON-HF trial.

If FDA approves use of sacubitril/valsartan in HF, it could become the first therapy indicated for use in HFpEF patients, as well as the first medication approved for major types of HF; HFpEF and HFrEF. A significant unmet need exists for treatment of HFpEF to reduce the burden of disease, as there are no approved therapies for HFpEF.

The decision of the Advisory Committee is based on the totality of evidence, including findings from a pre-specified subgroup analysis from PARAGON-HF, from PARAMOUNT (a phase II trial in HFpEF), and from PARADIGM-HF (a phase III trial in HFrEF).

A favorable safety profile for sacubitril/valsartan was observed in patients with HFpEF in the PARAGON-HF trial, in line with that observed in HFrEF, and clinical benefit of sacubitril/valsartan was shown in HFpEF patients.

Sacubitril/valsartan is approved in 115 countries worldwide for the treatment of HFrEF. It has been shown to reduce the rate of CV death and HF hospitalization, reduce the rate of all-cause mortality and improve aspects of health-related quality of life compared to enalapril.

Source: Press release Novartis, December 16, 2020