Farxiga is said to have reduced the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death, in Phase 3 DAPA-CKD trial
AstraZeneca has received the US Food and Drug Administration (FDA) approval for its sodium-glucose cotransporter 2 (SGLT2) inhibitor Farxiga (dapagliflozin) to treat people with a type of chronic kidney disease (CKD).
Farxiga is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with CKD, at risk of progression.
CKD is a condition characterised by a decline in kidney function and is often associated with an increased risk of heart disease or stroke, or the need for dialysis or kidney transplant.
In May last year, Farxiga was approved by the FDA for the treatment of eGFR to reduce the risk of CV death and hHF.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years.
“We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US.”
The US FDA approved Farxiga based on positive results from the Phase 3 DAPA-CKD trial, following its Priority Review designation granted earlier this year and breakthrough status last year.
In the Phase 3 trial, treatment with Farxiga, alongside standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, showed positive results in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
The treatment reduced the relative risk of worsening of renal function, the onset of ESKD, or risk of CV or renal death by 39% compared to placebo, the primary composite endpoint.
Farxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo, and the absolute risk reduction (ARR) was 5.3% for 2.4 years.
Also, analyses of the Phase 3 DECLARE-TIMI 58 trial, which evaluated the effect of Farxiga on CV outcomes showed that the drug is effective in patients with less advanced CKD.
In both clinical trials, Farxiga has demonstrated consistent safety and tolerability with the well-established safety profile of the treatment.
The drug is not advised for the treatment of CKD in patients with polycystic kidney disease or with a recent history of immunosuppressive therapy for kidney disease, or who require it.
DAPA-CKD trial executive committee co-chair Hiddo Heerspink said: “Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status.
“This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease.”