AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
The Food and Drug Administration (FDA) grants Priority Review to regulatory submissions for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Action date, the day the FDA targets for their regulatory decision, will be during the second quarter of 2021.
CKD, a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant. CKD is expected to become the world’s fifth leading cause of mortality by 2040. Currently in the US, 37 million people are estimated to have CKD.
“This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the US. Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type-2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
Clinical evidence from the DAPA-CKD Phase III trial
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 receivedBreakthrough 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.
Photo of Mene Pangalos: AstraZeneca