Farxiga US approval extended for heart failure patients
The US Food and Drug Administration (FDA) has approved an expanded use of AstraZeneca's Farxiga, enabling it to treat a broader range of adult patients with heart failure.
AstraZeneca's medication Farxiga (dapagliflozin) has received expanded approval in the United States. The U.S. Food and Drug Administration (FDA) has authorized the drug for adults with heart failure, regardless of their left ventricular ejection fraction (LVEF) status.
This new indication broadens Farxiga's use beyond its previous approval for patients with heart failure and reduced ejection fraction (HFrEF). The expansion is supported by positive results from the DELIVER Phase III clinical trial, which demonstrated the drug's efficacy in reducing cardiovascular death and hospitalisation for heart failure.
Heart failure affects millions globally and is a leading cause of hospitalisation, particularly for older adults. This expanded approval offers a new treatment option for patients with preserved or mildly reduced ejection fraction (HFpEF and HFmrEF), who have historically had fewer therapeutic choices.
Farxiga, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has shown benefits in managing cardiovascular conditions. It is already approved in over 100 countries for treating type 2 diabetes, heart failure, and chronic kidney disease.