AstraZeneca has reported positive results from the Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) in adults with chronic kidney disease (CKD).
Data found a statistically significant and clinically meaningful effect on its primary endpoint, which is a composite of renal function worsening or risk of death.
The trial also reached all secondary endpoints in CKD patients with and without type-2 diabetes (T2D). This is said to make Farxiga the first drug to significantly decrease the mortality risk from any cause in this patient population.
According to the results, the safety and tolerability profile of the drug was observed to be consistent with the established profile of the medicine.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos 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.”
Farxiga is an oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated to treat insufficiently controlled T2D in adults when given as an adjunct to diet and exercise for improving glycaemic control.
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial that assessed the efficacy of a 10mg dose of the drug compared to placebo in 4,304 patients with CKD Stages 2–4.
The drug was given once daily along with standard of care.
In March this year, AstraZeneca said that the DAPA-CKD trial was being stopped early based on an independent Data Monitoring Committee recommendation after review of efficacy data.
In May 2020, the drug was approved in the US to decrease the risk of CV death and hospitalisation for heart failure (hHF) in adults with HF who experienced reduced ejection fraction (HFrEF) with and without T2D.