AstraZeneca's Diabetes Drug Farxiga Scores FDA Nod In Kidney Disease

The FDA has approved AstraZeneca plc's AZN Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 inhibitor, to treat chronic kidney disease (CKD) even in patients without diabetes.
Under the new approval, Farxiga can be used to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD.
The FDA approved the strength of the Dapa-CKD trial that enrolled 4,304 kidney disease patients with stages 2-4 disease and high levels of albumin in their urine.
In that study, Farxiga plus standard of care slashed the combined risk of worsening kidney function or death from cardiovascular or kidney problems by 39% compared with placebo. The drug also cut mortality risk from any cause by 31%.
In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D).
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