Farxiga Receives New Indication for Heart Failure

May 6, 2020 – The U.S. FDA has approved a new indication for Farxiga® (dapagliflozin) oral tablets, manufactured by AstraZeneca. The drug is now indicated to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults who have heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) either with or without type 2 diabetes. Previously, Farxiga was only approved for use in patients who have diabetes to both improve glycemic control and reduce the risk of hospitalization for heart failure.

Heart failure affects an estimated 6.5 million people in the United States, with 50% of patients dying within five years of diagnosis. In heart failure with reduced ejection fraction (HFrEF), the left ventricle of the heart is unable to contract properly and does not send enough oxygen-rich blood into the body. Causes include high blood pressure, coronary artery disease, heart attack, viral infections of the heart, irregular heart rhythm, and issues with the aortic or mitral valves of the heart.

In a clinical trial, Farxiga reduced the risk of CV death or worsening of heart failure by 26% versus placebo in patients who have HFrEF. It also reduced the need for hospitalization due to heart failure. Recommended dosing under the new indication is 10mg once daily.

Farxiga is the first SGLT2 inhibitor to receive FDA approval for the treatment of HFrEF. The drug received its initial FDA approval in 2014.