Therapy Areas: Diabetes
AstraZeneca's Farxiga granted FDA Priority Review for treatment of chronic kidney disease
6 January 2021 -

Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) said on Wednesday that Farxiga (dapagliflozin) has been granted Priority Review in the United States for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The Prescription Drug User Fee Action date, the day the US Food and Drug Administration (FDA) targets for its 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.

The 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.

In a Phase III trial, Farxiga plus 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 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% compared to placebo.

Farxiga is currently indicated in the US as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. In May 2020 it 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.