FDA Approves Dapagliflozin to Treat CKD
The U.S. Food and Drug Administration (FDA) on May 3 approved dapagliflozin (Farxiga) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease (CKD) who are at risk of disease progression. This announcement comes after the FDA approved dapagliflozin oral tablets in 2020 for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.
FDA approval was based on results from the DAPA-CKD trial, which involved 4,304 participants and showed that dapagliflozin results in salutary effects on renal function and mortality among patients with CKD, irrespective of diabetes mellitus status.
"Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes," said Aliza Thompson, MD, MS, deputy director of the Division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research.
Dapagliflozin "was not studied" and is "not expected to be effective" in treating CKD among patients with autosomal dominant or recessive polycystic kidney disease, or among patients who "require or have recently used immunosuppressive therapy to treat kidney disease," the FDA stated.
Keywords: ACC Advocacy, Drug Evaluation, Public Health, United States Food and Drug Administration, Heart Failure, Renal Insufficiency, Renal Insufficiency, Chronic, Polycystic Kidney Diseases, Disease Progression, Diabetes Mellitus
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