The US Food and Drug Administration (FDA) has approved AstraZeneca’s (AZ) oral SGLT2 inhibitor Farxiga for the treatment of chronic kidney disease (CKD) in adults at risk of progression, with and without type 2 diabetes.
The approval, which has been labelled an “important step forward in helping people living with kidney disease”, is based on results from the Phase III DAPA-CKD trial and follows a priority review designation granted by the FDA earlier this year.
In the DAPA-CKD trial, Farxiga plus standard-of-care treatment reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD) or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with stages 2-4 CKD and elevated urinary albumin excretion.
In addition, the absolute risk reduction was 5.3% over the median time in study of 2.4 years, with Farxiga also significantly reducing the relative risk of death from any cause by 31% compared to placebo.
“[This] approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
"We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US,” he added.
Farxiga is already approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in the US, and also to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and established CV disease or multiple CV risk factors.
The oral SGLT2 inhibitor is also indicated to reduce the risk of CV death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.