Farxiga has been shown to significantly reduce the worsening of renal function or risk of death in patients with chronic kidney disease with and without Type 2 diabetes.
High-level results from Farxiga’s (dapagliflozin) Phase III DAPA-CKD trial showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death in adult patients with chronic kidney disease.
The trial also met all its secondary endpoints in chronic kidney disease patients with and without Type 2 diabetes, making Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population.
Chronic kidney disease is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed. Currently, there are limited treatment options for these patients. chronic kidney disease is associated with significant patient morbidity and an increased risk of cardiovascular events, such as heart failure and premature death.
The co-chairs of the trial and its Executive Committee Professor David Wheeler, University College London, and Professor Hiddo L. Heerspink, University Medical Center Groningen, said: “The DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment option for patients with chronic kidney disease. The data will be transformative for these patients.”
The safety and tolerability profile for Farxiga was consistent with the well-established safety profile of the medicine. The full DAPA-CKD trial results will be submitted for presentation at a forthcoming medical meeting.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without Type 2 diabetes. We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”
In March 2020, AstraZeneca announced that the DAPA-CKD trial was being stopped early following a recommendation from an independent Data Monitoring Committee based on its determination of overwhelming efficacy. Additionally, in May 2020, Farxiga was approved in the US 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. Farxiga is also under review with the European Medicines Agency, as well as in other regions, for the treatment of patients with heart failure.