Approvals

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Farxiga to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) hospital visits for adults with HF.

This additional approval is based on positive data from the DELIVER phase 3 trial. The drug was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).

The data from the DELIVER phase 3 trial showed Farxiga reaching 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.

Full results of the trial were published in The New England Journal of Medicine while an analysis of the trial was published in Nature Medicine; these demonstrated that treatment with 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 (SGLT2) inhibitor to demonstrate a mortality benefit,’ according to the company’s press release.

Ruud Dobber, executive vice president of the BioPharmaceuticals Business Unit at AstraZeneca, commented: “Approximately half of HF patients die within five years of diagnosis, highlight[ing] 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 HF lead healthier lives.”