AstraZeneca's Diabetes Drug Farxiga Scores FDA Nod In Kidney Disease
- The FDA has approved AstraZeneca plc's (NASDAQ: 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).
- Price Action: AZN shares are up 0.7% at $53.44 in the premarket session on the last check Monday.
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