AstraZeneca has been granted breakthrough therapy designation (BTD) for Farxiga (dapagliflozin) from the US Food and Drug Administration (FDA) for the treatment of patients with chronic kidney disease (CKD), irrespective of type 2 diabetes (T2D).
According to the US Centers for Disease Control and Prevention (CDC), chronic kidney disease is a serious, progressive condition defined by reduced kidney function. Chronic kidney disease is associated often with a heightened risk of heart disease or stroke.
The breakthrough therapy designation from the FDA is designed to fast track the development and regulatory review of potential new drugs that are intended for the treatment of a serious condition apart from addressing a significant unmet medical need.
The SGLT2 inhibitor has to deliver promising early clinical results that show significant improvement on a clinically significant endpoint over available medicines.
The FDA breakthrough therapy designation for Farxiga in chronic kidney disease was granted based on clinical results of the DAPA-CKD trial. The results showed that Farxiga on top of the standard of care cut down the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with chronic kidney disease while also considerably reducing death from any cause by 31%, in comparison to placebo.
Mene Pangalos – Executive Vice President of AstraZeneca BioPharmaceuticals R&D 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.”
Farxiga has been approved by the FDA as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes and to cut down the risk of hospitalization for heart failure in patients with type 2 diabetes and established CV disease or multiple CV risk factors.
In May, SGLT2 inhibitor was approved by the FDA to cut down the risk of CV death and hospitalization for heart failure (hHF) in adults with heart failure (HF) (NYHA class II-IV) with reduced ejection fraction (HFrEF), irrespective of having type 2 diabetes.
Farxiga has not been approved for reducing the worsening of renal function or death in patients with chronic kidney disease.
In July, AstraZeneca secured fast track designation for Farxiga from the FDA for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack.