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News From the Food and Drug Administration
August 18, 2015

Heart Failure Drug Gains Approval

JAMA. 2015;314(7):662. doi:10.1001/jama.2015.9770

The FDA has approved sacubitril/valsartan, marketed as Entresto, to treat patients with heart failure. The drug was granted fast-track designation as a medication that treats a serious or life-threatening condition and fills an unmet medical need.

In a trial including more than 8000 adults, Entresto was shown to reduce the rate of cardiovascular death and hospitalizations associated with heart failure compared with another drug, enalapril (http://1.usa.gov/1Uxv4Dv). Most patients in the study also took other approved heart failure medications, including β-blockers, diuretics, and mineralocorticoid antagonists.

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