AstraZeneca announced that its diabetes drug Farxiga (dapagliflozin) has demonstrated promising results in Phase 3 DAPA-CKD trial for the treatment of adult patients with chronic kidney disease (CKD).
The study has met the primary endpoint of reducing worsening of renal function or risk of death, including a decline in estimated glomerular filtration rate (eGFR), the onset of end-stage kidney disease (ESKD) or cardiovascular (CV) or renal death in patients with CKD.
Phase 3 trial has also met all its secondary endpoints in kidney patients with and without type-2 diabetes (T2D), making Farxiga the first drug to minimise the death risk from any cause in the patients, said the company.
CKD is a serious, progressive condition characterised by reduced kidney function, and often related to the increased risk of CV events, including heart failure (HF) and premature death. Patients affected by the disease are left with limited treatment options.
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 now being evaluated in DELIVER and DETERMINE trials
DAPA-CKD is a global, multi-centre, randomised, double-blinded clinical trial designed to evaluate the efficacy of Farxiga 10mg, compared to placebo, in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without T2D, across 21 countries.
Farxiga is an advanced, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated for the treatment of insufficiently controlled T2D in adults, as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction.
The drug is now being evaluated for HF patients in the DELIVER and DETERMINE trials.
In the late-stage study, Farxiga has demonstrated a consistent safety and tolerability profile with the well-established safety profile of the medicine.
The British drugmaker has announced the early closure of DAPA-CKD in March 2020, after an independent Data Monitoring Committee recommended the determination of its overwhelming efficacy.
DAPA-CKD trial executive committee co-chair David Wheeler 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.”
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.”
