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DAPA-CKD Phase III trial showed that Farxiga, on top of standard of care consisting of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of worsening renal function or risk of cardiovascular or renal death by 39%.
In the subgroup analysis, compared to placebo Farxiga showed a relative risk reduction of 37% for patients whose CKD was primarily driven by diabetic kidney disease; 57% for glomerulonephritis; and 42% for CKD of other or unknown causes.
Designation follows DAPA-CKD Phase III trial results in which Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease.
Results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in CKD patients.
Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes .
FARXIGA significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type 2 diabetes.
Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on a conclusive signal of efficacy in the prevention of the primary endpoint.
The decision was made following a routine assessment of efficacy and safety which showed Farxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.