Farxiga Granted Priority Review for Patients With Heart Failure

The FDA granted priority review for AstraZeneca’s sNDA for Farxiga (dapagliflozin) for reducing the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type 2 diabetes.

The sNDA was based on the results of a phase 3 clinical trial, in which Farxiga with standard care reduced the incident of cardiovascular death or the worsening of heart failure versus placebo.

The agency approved Farxiga in October 2019 to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease or multiple CV risk factors.