AstraZeneca’s Farxiga Gains Extended FDA Approval to Treat a Broader Range of Patients

May 9, 2023—AstraZeneca announced that Farxiga (dapagliflozin) has been approved in the United States to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF), and urgent heart failure (HF) visits in adults with HF. Previously, Farxiga was approved in the United States for adults with HF with reduced ejection fraction (HFrEF).

According to the company, the FDA approval was based on results from the DELIVER phase 3 trial, which showed Farxiga reached a statistically significant and clinically meaningful early reduction in the primary composite endpoint of CV death or worsening HF in patients with HF with mildly reduced ejection fraction or preserved ejection fraction.

Scott D. Solomon, MD, et al published the DELIVER findings in The New England Journal of Medicine (2022;387:1089-1098).

Additionally, results from a prespecified, pooled analysis of the DAPA-HF and DELIVER phase III trials showed that the treatment effect of Farxiga on the composite endpoint of CV death, hHF, or urgent HF was consistent across the left ventricular ejection fraction (LVEF) range and established Farxiga as the first sodium-glucose cotransporter 2 inhibitor to demonstrate a mortality benefit, stated the company. The pooled analysis findings were published by Professor Pardeep S. Jhund, MBChB, et al in Nature Medicine (2022;28:956-1964).

AstraZeneca advised that Farxiga is approved for the treatment of patients with type 2 diabetes, HFrEF, and chronic kidney disease in more than 100 countries including the United States, the European Union, China, and Japan. It has most recently received regulatory approvals in the European Union, Great Britain, Japan, and Turkey to extend the HF indication to include patients across the full LVEF range.