Dapagliflozin gains FDA approval for CKD indication
medwireNews: The FDA has approved use of dapagliflozin to reduce the risk for cardiorenal events in people with chronic kidney disease (CKD), irrespective of whether they have type 2 diabetes.
This is based on the positive outcomes of the DAPA-CKD trial, in which all participants had CKD, but only around two-thirds had diabetes.
According to the FDA statement, dapagliflozin is approved “to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure” in people with CKD that is likely to progress.
But it cautions that this excludes CKD due to polycystic kidney disease or autoimmune causes.
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