The US regulatory agency granted the breakthrough status for Farxiga based on the positive clinical evidence from the Phase 3 DAPA-CKD trial
AstraZeneca New Cambridge R&D centre and global headquarters aerial view. (Credit: AstraZeneca.)
AstraZeneca has secured the US Food and Drug Administration (FDA) breakthrough therapy designation for Farxiga (dapagliflozin) to treat patients with chronic kidney disease (CKD), regardless of type-2 diabetes (T2D).
The British drugmaker said that the US regulatory agency has granted breakthrough therapy designation for Farxiga based on the positive clinical evidence from the Phase 3 DAPA-CKD trial.
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial, which evaluated the efficacy of Farxiga 10mg, compared with placebo, in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, regardless of T2D.
AstraZeneca stated that worsening of renal function or risk of death is the primary composite endpoint, while the secondary endpoints included the time to the first occurrence of the renal composite, the composite of CV death or hHF, and death from any cause.
The study results, released in August 2020, showed that Farxiga plus standard of care reduced the worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo, reducing death from any cause by 31% compared to placebo.
AstraZeneca to work with FDA to make Farxiga available to patients soon
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease.
“Following the ground-breaking DAPA-CKD results, the breakthrough therapy designation is further testament to Farxiga’s potential to slow the progression of chronic kidney disease. We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”
CKD is a serious, progressive condition of decline in kidney function, shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months.
The company said that that the most severe form of the disease is known as end-stage kidney disease (ESKD), and it requires dialysis or kidney transplantation.
Diabetes, hypertension and glomerulonephritis are the most common causes of CKD. The disease is often associated with patient morbidity and elevated risk of CV events, including heart failure (HF) and premature death.
Farxiga is an oral, once-daily sodium-glucose co-transporter-2 inhibitor indicated for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction.
The drug is approved in the US to improve glycaemic control in adults with T2D along with diet and exercise, and reduce the risk of hospitalisation for heart failure (hHF) and established CV disease or multiple CV risk factors in T2D patients.
In May 2020, Farxiga was approved in the US to reduce the risk of CV death and hHF in adults with heart failure (HF) with reduced ejection fraction (HFrEF) with and without T2D.