In a groundbreaking Phase III trial AstraZeneca’s Farxiga has shown reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease.
Detailed results from the Phase III DAPA-CKD trial have shown that AstraZeneca’s Farxiga (dapagliflozin) reduced the composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo in patients with chronic kidney disease at stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without Type 2 diabetes.
Chronic kidney disease is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed, and the most common causes are diabetes, hypertension, and glomerulonephritis.
Improving mortality in kidney patients
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without Type 2 diabetes. The primary composite endpoint was 50% sustained decline in estimated glomerular filtration rate, onset of end-stage kidney disease (and cardiovascular or renal death. The absolute risk reduction was 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% compared to placebo.
The co-chairs of the DAPA-CKD trial and its Executive Committee Professor David Wheeler, University College London, UK and Professor Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, said: “The impressive DAPA-CKD trial results are a remarkable development for patients with chronic kidney disease. These data have the potential to transform the standard of care for this patient population, which has a significant unmet need for new and improved treatment options.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world. Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without Type 2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in Type 2 diabetes.”
In May 2020, Farxiga was approved in the US to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction with and without Type 2 diabetes. Farxiga is currently being assessed in patients with heart failure in the DELIVER (heart failure with preserved ejection fraction) and DETERMINE trials, as well as in patients without Type 2 diabetes following an acute myocardial infarction or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomised controlled trial.