FDA grants expanded indication for sacubitril/valsartan in chronic heart failure

This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined HFpEF2,5,6. The greatest benefit was shown in patients with LVEF below normal6.

Approximately 6 million Americans are living with chronic heart failure (CHF)4. Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal2-4. The prevalence of heart failure (HF) is increasing as the population ages4. Patients often face worsening symptoms that result in frequent HF hospitalizations7. Each hospitalization event is associated with worsening long-term prognosis7. Approximately one in four patients are re-admitted for HF and 10 percent may die within 30 days of discharge8,9. Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a HF diagnosis4.

"We are proud of our goal to reimagine medicine. This commitment has enabled us to bring Entresto to millions more heart failure patients in the US, many of whom did not have an approved treatment option until now," said Marie-France Tschudin, President, Novartis Pharmaceuticals. "This achievement would not have been possible without tremendous dedication from investigators, patients in our clinical trials and the advocacy community, to whom we are extremely grateful."