AstraZeneca Gets Fast Track for Kidney Disease Treatment
The FDA granted AstraZeneca fast track designation for Farxiga (dapaglifozin) to delay renal failure and prevent cardiovascular and renal deaths in patients with chronic kidney disease.
The drug is an oral, once-daily SGLT2 inhibitor indicated as both a monotherapy and as part of combination therapy to improve glycemic control. The designation was granted for chronic kidney disease patients with or without type 2 diabetes.
AstraZeneca is currently sponsoring a phase 3 clinical trial to evaluate the effect of Farxiga on patients with chronic kidney disease, with or without type 2 diabetes, on top of standard care.