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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AstraZeneca’s Farxiga met primary endpoint in Phase 3 heart failure trial 

AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study. 

First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney disease. 

AstraZeneca now says that data from the DELIVER and DAPA-HF Phase 3 studies show its efficacy in heart failure regardless of ejection fraction. 

In the two studies, the safety profile of Farxiga was consistent with prior data.

Farxiga’s biggest competitor is Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, first approved in 2014 for type 2 diabetes. Jardiance now has two FDA indications related to heart failure.

Another competitor is the heart failure drug Entresto (sacubitril/valsartan) from Novartis, which had $2.8 billion in sales in …

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