Fast Track designation for AstraZeneca’s therapy in chronic kidney disease

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of a new therapy to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).

Farxiga (dapagliflozin) is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D. 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.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Chronic kidney disease affects an estimated 37 million people in the US, and is often associated with an increased risk of heart disease and stroke. This Fast Track designation is an important step towards more quickly addressing unmet treatment needs in chronic kidney disease, and we will work closely with the FDA to explore the potential for Farxiga to improve outcomes for these patients.”

The Phase III DAPA-CKD clinical trial is currently underway to evaluate the effect of Farxiga on renal outcomes and CV mortality in patients with CKD with and without T2D versus placebo, on top of standard of care.

CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate (eGFR), markers of kidney damage, or both, for at least three months. The most common causes of CKD are diabetes and hypertension. CKD affects an estimated 200 million adults globally.

CKD is associated with increased risk of therapy-resistant hypertension, chronic fluid overload, heart failure, and CV and all-cause death. In its most severe form, known as end-stage renal disease (ESRD), kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required. The majority of patients with ESRD will die from CV causes.

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