AstraZeneca PLC ($AZN) announced remarkable numbers about the Farxiga study that includes positive data for the Phase III. The study result shows a significant decrease in the risk of renal failure, cardiovascular or renal death in patients suffering from chronic kidney disease. Further data from the Phase III DAPA-CKD study showed that Farxiga – in combination with standard of care – reduced the composite measure of deterioration in renal function, the risk of cardiovascular or renal death by 39% compared to placebo.
The study results are promising
The results revealed that the actual risk reduction was 5.3% over the median period of the 2.4-year sample. While the primary finding of the study was ≥50 percent sustained reduction in expected glomerular filtration rate (eGFR), initiation of end-stage kidney disease (ESKD) and CV or renal death. With this Farxiga is the first SGLT2 inhibitor that shows to substantially improve the survival of patients with chronic kidney disease with and without type 2 diabetes. Furthermore, the drug candidate reached all of the secondary endpoints. These secondary endpoints were primarily concerned with a mortality rate. The results indicated a substantial decrease in mortality from any cause by 31% compared to placebo.
The safety and tolerability profile of Farxiga was consistent with the well-established safety profile of the drug. The participants given the drug candidate reported less serious adverse reactions compared to placebo. 29.5% of patients on Farxiga reported events compared to 33.9% of placebo patients reporting the same cases.
This treatment is a one of a kind
Farxiga is the first treatment to demonstrate the capacity for both chronic kidney disease and heart failure in patients with and without type 2 diabetes. The risk of hospitalization for heart disease and nephropathy in type 2 diabetes is also expected to decrease. Earlier this year, the drug candidate was approved by the FDA to minimize the risk of cardiovascular death and hospitalization for cardiac failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. At this point there are two trials for the treatment of heart failure. The DELIVER study focuses on heart failure with preserved ejection fraction, while the DETERMINE study deals with HFrEF and HFpEF.
The background of Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction. In the DECLARE CV outcomes trial in adults with T2D, Farxiga reduced the risk of the composite endpoint of hospitalisation for HF or CV death versus placebo, when added to standard of care.
It’s currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials. Farxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomised controlled trial. Farxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.
What does DAPA-CKD stands for?
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D. Farxiga is given once daily in addition to standard of care. The primary composite endpoint is worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of ESKD and death from CV or renal cause). The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD and renal death), the composite of CV death or hHF, and death from any cause. The trial was conducted in 21 countries.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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