FDA approves expanded use of Farxiga (dapagliflozin) for heart failure patients regardless of ejection fraction status

FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin). This decision, marking a significant milestone in Farxiga’s development, opens up its use in patients with heart failure, regardless of their ejection fraction status. This brings the total number of Farxiga’s approved indications to five.

Ejection fraction in heart failure

Ejection fraction is a key measure of how well the heart is pumping and is used in diagnosing and monitoring heart failure. The recent approval means that Farxiga can be used in patients with heart failure, whether their ejection fraction is preserved (a measure above 40%) or reduced (below 40%).

“Initially, we were indicated for heart failure with reduced ejection fraction (HFrEF), and with the recent extension we received, we are now approved for heart failure with preserved ejection fraction (HFpEF) as well,” says Sarah Walters, VP of U.S. cardiovascular, renal and metabolic di…

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