The FDA has approved dapagliflozin to reduce the risk of adverse renal events, cardiovascular death and hospitalization for heart failure in adult patients with chronic kidney disease.
“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,” Aliza Thompson, MD, MS, deputy director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
The FDA reached its decision using data from a multicenter, double-blind study of more than 4,300 patients who were randomly assigned to either receive dapagliflozin or a placebo. Overall, researchers found, the medication was associated with a lower risk of adverse renal and cardiovascular outcomes.
Dapagliflozin, known primarily as an effective treatment for Type 2 diabetes, is manufactured by AstraZeneca under the name Farxiga.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.