Last year, a data monitoring committee halted the DAPA-CKD trial when it found the evidence of efficacy was overwhelming, after it was shown the trial met all its primary and secondary end points for patients with chronic kidney disease, with and without type 2 diabetes.
The FDA Friday approved oral dapagliflozin (Farxiga) 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.
Last year, a data monitoring committee halted the DAPA-CKD trial when it found the evidence of efficacy was overwhelming, after it was shown the trial met all its primary and secondary end points for patients with chronic kidney disease (CKD), with and without type 2 diabetes (T2D). Later in 2020, dapagliflozin was approved for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without T2D, marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.
Dapagliflozin, from AstraZeneca, was the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved to treat adults with HFrEF.
In a statement, the FDA said the efficacy of dapagliflozin to improve kidney outcomes and reduce cardiovascular death in patients with CKD was evaluated in a multicenter, double-blind study, where 4304 patients were randomly assigned to receive either dapagliflozin or a placebo.
The study compared the 2 groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death.
Results showed that 197 of the 2152 patients who received dapagliflozin had at least 1 of the composite endpoint events, compared with 312 of the 2152 patients who received a placebo.
The study also compared the 2 groups for the number of patients who were hospitalized for heart failure or died from cardiovascular disease. A total of 100 patients who received dapagliflozin were hospitalized or died compared with 138 patients who received a placebo.
“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 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.”