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AstraZeneca Says Farxiga DAPA-CKD Trial Met All Endpoints

Farxiga significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type-2 diabetes  

Benzinga · -
Farxiga significantly reduced 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 (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in adult patients with chronic kidney disease (CKD). The trial also met all its secondary endpoints in CKD patients with and without type-2 diabetes (T2D), making Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population.   CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide,1,2 many of them still undiagnosed.3,4 Currently there are limited treatment options for these patients.5 CKD is associated with significant patient morbidity and an increased risk of CV events,6 such as heart failure (HF) and premature death.7   The co-chairs of the trial and its Executive Committee Prof. David Wheeler, University College London, and Prof. 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."   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."   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.   In March 2020, AstraZeneca (NYSE: AZN) 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 (hHF) in adults with HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. Farxiga is also under review with the European Medicines Agency, as well as in other regions, for the treatment of patients with HF.