AstraZeneca (AZN,AZN.L), on Tuesday, announced that the FDA has approved its Farxiga in the US to reduce the risk of cardiovascular or CV death, hospitalisation for heart failure or hHF and urgent heart failure or HF visits in adults with HF.
The approval by the Food and Drug Administration or FDA was based on positive results from the DELIVER Phase III trial.1 Farxiga was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).
Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca, said, "Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death. The approval of Farxiga in the US not only reinforces AstraZeneca's commitment to reducing the burden of this complex and life-threatening disease, but will help patients across the full spectrum of heart failure lead healthier lives."
The data from the DELIVER Phase III trial, published in The New England Journal of Medicine, 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 HfpEF.
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 cardiovascular death, hospitalisation for heart failure or urgent heart failure was consistent across the left ventricular ejection fraction (LVEF) range and established Farxiga as the first sodium-glucose cotransporter (SGLT2) inhibitor to demonstrate a mortality benefit.
The company stated that its Farxiga is approved for the treatment of patients with type-2 diabetes (T2D), HFrEF and chronic kidney disease (CKD) in more than 100 countries around the world including the US, the European Union (EU), China and Japan. It has most recently received regulatory approvals in the EU, Great Britain, Japan and Turkey to extend the HF indication to include patients across the full LVEF range.
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