(RTTNews) - Biopharmaceutical company AstraZeneca plc (AZN.L, AZN) announced Tuesday that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). CKD affects an estimated 37 million people in the US.
The FDA's Fast Track program is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.
The designation was assigned to CKD patients with and without type 2 diabetes (T2D). CKD is associated with increased risk of therapy-resistant hypertension, chronic fluid overload, heart failure, and CV and all-cause death.
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.
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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