AstraZeneca Farxiga gets approval in US for CKD prevention

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "The approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years. 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."

The DAPA-CKD trial demonstrated that Farxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of CV or renal death by 39%, the primary composite endpoint, compared to placebo (p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. Farxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo.

Exploratory analyses of the DECLARE-TIMI 58 Phase III trial, a randomised, double-blind, placebo-controlled trial, conducted to determine the effect of Farxiga on CV outcomes support the conclusion that Farxiga is also likely to be effective in patients with less advanced CKD.

In both trials, the safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine.

In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D), and to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors. Farxiga is also indicated to reduce the risk of CV death and hHF in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.