FDA Grants Priority Review to Dapagliflozin for Chronic Kidney Disease Indication

The agency granted priority review to dapagliflozin (Farxiga; AstraZeneca) for the treatment of new or worsening chronic kidney disease in adults with and without type 2 diabetes.

Officials with the FDA have granted priority review to AstraZeneca’s dapagliflozin (Farxiga) for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes.1

In the US, dapagliflozin is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors. Dapagliflozin was approved in May 2020 to reduce the risk of CV death and hospitalization for heart failure (HF) in adults with HF with reduced ejection fraction with and without type 2 diabetes.1

The agency’s decision to grant priority review for this indication is based on clinical data from the DAPA-CKD phase 3 study, which were published in The New England Journal of Medicine in August 2020.1

Investigators assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 mL per minute per 1.73 m2 of the body-surface area and a urinary albumin-to-creatinine ratio of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.2

The results showed that, on top of standard of care consisting an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), dapagliflozin reduced the risk of the composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared with placebo (absolute risk reduction [ARR] 5.3%, p<.0001) in patients with CKD stages 2 to 4 and elevated urinary albumin excretion. Dapagliflozin also significantly reduced the risk of death form any cause by 31% (ARR 2.1%, p=.0035) compared with placebo.2

The independent data monitoring committee recommended stopping the trial early because of dapagliflozin’s demonstrated efficacy.2

“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,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in a statement.1 “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.”

The Prescription User Fee Acton date for this indication will be during the second quarter of 2021.1

References

  1. Farxiga granted Priority Review in the US for the treatment of patients with chronic kidney disease. News release. AstraZeneca; January 6, 2021. Accessed January 7, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/farxiga-granted-us-priority-review-for-ckd.html
  2. Heerspink HJL. Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. The New England Journal of Medicine. 2020. Doi: 10.1056/NEJMoa2024816.