AstraZeneca has reported positive data from the Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) plus standard of care in chronic kidney disease (CKD) Stages 2-4 patients with increased urinary albumin excretion.
When compared to placebo, the drug combination decreased the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39%.
This data was observed to be consistent in patients with and without type-2 diabetes (T2D).
Farxiga is an oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor. The international, multi-centre, randomised, double-blinded DAPA-CKD study assessed the efficacy of 10mg dose of the drug in a total of 4,304 patients across 21 countries.
The drug was given once daily on top of standard of care. The primary composite endpoint was worsening of renal function or risk of death.
Meanwhile, the secondary endpoints included the time to first occurrence of the renal composite, the composite of CV death or hospitalisation for heart failure (hHF), and death from any cause.
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According to the trial results, the primary composite endpoint was ≥50% sustained reduction in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death.
The absolute risk reduction (ARR) was reported to be 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significant decrease in death from any cause by 31%.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “With today’s results, 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.”
The safety and tolerability of the drug were found to be consistent with its established safety profile. In the DAPA-CKD trial, patients treated with Farxiga reported fewer serious adverse events versus placebo.
Last week, AstraZeneca started dosing participants in a Phase I trial of monoclonal antibody (mAb) combination therapeutic AZD7442 to prevent and treat Covid-19.