AstraZeneca has reported positive data from a subgroup analysis from Phase III DAPA-CKD trial of Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD).
The trial data showed that Farxiga helped reduce the composite of worsening of kidney function or risk of cardiovascular (CV) or renal death.
Farxiga is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used for treating patients with insufficiently controlled type-2 diabetes (T2D).
The international, multi-centre, randomised and double-blinded DAPA-CKD trial was conducted on 4,304 patients.
It analysed the efficacy of 10mg dose of Farxiga as compared to placebo, in patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without T2D.
According to data from the subgroup analysis, Farxiga showed a relative risk reduction (RRR) of 37% for patients whose CKD was primarily driven by diabetic kidney disease as compared to placebo.
It also showed a RRR of 25% for high blood pressure, 57% for glomerulonephritis, and 42% for CKD of other or unknown causes.
Moreover, the drug demonstrated a reduction in all-cause mortality, a secondary outcome.
The drug’s safety and tolerability profiles were consistent with the previously-established ones.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “The DAPA-CKD trial showed the potential of Farxiga as the first SGLT2 inhibitor to significantly prolong survival in a renal outcomes trial in patients with chronic kidney disease with and without type-2 diabetes.
“The new data presented further demonstrate Farxiga’s consistent and clinically meaningful benefit across a diverse group of patients with chronic kidney disease, a population in urgent need of new treatment options to slow the progression of their disease.”
In August, AstraZeneca reported data from the Phase III DAPA-CKD trial of Farxiga plus standard of care in CKD Stages 2-4 patients with increased urinary albumin excretion.