Farxiga extended by the FDA to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients.- AstraZeneca
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF.
The approval by the FDA was based on positive results from the DELIVER Phase III trial. Farxiga was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).
The data from the DELIVER Phase III trial, published in The New England Journal of Medicine,(previously cited) 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 HFmrEF or HFpE.F. The results from a pre-specified, pooled analysis of the DAPA-HF and DELIVER Phase III trials, published in Nature Medicine, showed that the treatment effect of Farxiga on the composite endpoint of CV, hHF and urgent HF was consistent across the left ventricular ejection fraction (LVEF) range and established Farxiga as the first sodium-glucose cotransporter 2 (SGLT2) inhibitor to demonstrate a mortality benefit.
See-"Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER"; Pardeep S. Jhund, Toru Kondo, Jawad H. Butt, Kieran F. Docherty, Brian L. Claggett, et.al., Nature Medicine volume 28, pages1956–1964 (2022).
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