AstraZeneca gets USFDA Priority Review for Farxiga to treat chronic kidney disease

The acceptance of the regulatory submission by the FDA and the granting of Priority Review was based on clinical evidence from the DAPA-CKD Phase III trial. The trial showed that Farxiga, on top of standard of care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced the risk of the composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39%, the primary endpoint, compared to placebo (absolute risk reduction [ARR] 5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. It also significantly reduced the risk of death from any cause by 31% (ARR 2.1%, p=0.0035) compared to placebo. The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine.

In March 2020, an independent Data Monitoring Committee recommended the trial be stopped early, based on its determination of overwhelming efficacy. Detailed results from the DAPA-CKD trial were shared in August 2020 and published in The New England Journal of Medicine.

In October 2020, Farxiga received Breakthrough Therapy Designation in the US for patients with CKD with and without T2D. In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. In May 2020 Farxiga was approved in the US to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.

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