AstraZeneca announced 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 greater than 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.
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.”
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 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.