Old Drug, New Indication? An expanded approval for the use of Entresto™

Old Drug, New Indication? An expanded approval for the use of Entresto™
Lauren Martens, PharmD, CentraCare St. Cloud

While previously indicated for use solely in those with heart failure with reduced ejection fraction, sacubitril/valsartan (Entresto) is now approved for use in a larger population. The expanded approval came following the results of the PARAGON-HF study, which compared valsartan to sacubitril/ valsartan in patients with an ejection fraction of at least 45%. The primary outcome was a composite of heart failure hospitalizations and cardiovascular death, and while it was not found to be statistically significant, benefit was seen in patients that had an ejection fraction in the lower proportion (45-57%) of those included. Based on these findings, sacubitril/valsartan is now approved for use in patients with an ejection fraction below normal. This expanded approval did not specify an ejection fraction cutoff, therefore requiring the use of clinical judgment when determining which patients are appropriate for use as ejection fraction can vary between patients. As the first approved therapy for both those with heart failure with reduced and preserved ejection fraction, sacubitril/valsartan now has the potential to benefit the majority of patients with heart failure.   

 

References:

  1. Walter K. FDA approves new indication for Entresto for patients with LVEF below normal. HCPLive. https://www.hcplive.com/view/fda-approves-new-indication-entresto-patien.... Published February 16, 2021. Accessed April 28, 2021. 

  2. Solomon SD, McMurray JJV, Anand IS, et al. Angiotensin–neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med. 2019;381(17):1609-1620. doi:10.1056/nejmoa1908655 

  3. Neale T. New FDA indication opens up use of sacubitril/valsartan in HFpEF. TCTMD.com. https://www.tctmd.com/news/new-fda-indication-opens-use-sacubitrilvalsar.... Published February 16, 2021. Accessed May 10, 2021.