AstraZeneca has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for Farxiga (dapagliflozin) in chronic kidney disease (CKD) patients, with and without type 2 diabetes (T2D).
Farxiga is an oral, once-daily sodium-glucose co-transporter-2 inhibitor (SGLT2 inhibitor).
Its breakthrough therapy designation in chronic kidney disease was driven by the findings of phase 3 DAPA-CKD trial.
Results from the late-stage study revealed that Farxiga in addition to the standard of care brought down the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39%. This is in comparison to placebo in patients with CKD stages 2-4 and elevated urinary albumin excretion, irrespective of T2D.
The SGLT2 inhibitor could also substantially lower the risk of death from any cause by 31%, compared to placebo, which is one of the secondary endpoints of the trial.
The US Centers for Disease Control and Prevention (CDC) defines chronic kidney disease as a serious, progressive condition that is characterised by reduced kidney function. Chronic kidney disease is typically related to an increased risk of heart disease or stroke.
FDA’s breakthrough therapy designation helps in speeding up the development and regulatory review of potential new medicines that are intended for the treatment of a serious condition apart from addressing a significant unmet medical need.
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 in the US as quickly as possible.”
The SGLT2 inhibitor has the FDA approval for boosting glycemic control in adults with type 2 diabetes and as an adjunct to diet and exercise. It is also indicated in the US for lowering the risk of hospitalisation for heart failure in patients having type 2 diabetes and established CV disease or various CV risk factors.
However, it does not have approval for decreasing the worsening of renal function or death in patients having chronic kidney disease.
In July 2020, AstraZeneca was granted FDA fast track designation for Farxiga for its use in reducing the risk of heart failure.
The fast track status is for the use of the SGLT2 inhibitor in decreasing the chances of CV death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF), or preserved ejection fraction (HFpEF).