FDA approves Farxiga for CKD
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The FDA approved Farxiga for the treatment of CKD among adult patients with CKD who are at risk for disease progression.
According to a press release, Farxiga (dapagliflozin; AstraZeneca), has been approved as an oral tablet to reduce the risk for kidney function decline, kidney failure, cardiovascular death and hospitalization related to heart failure among patients with CKD.
“CKD 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 the release. “Today’s approval of Farxiga for the treatment of CKD is an important step forward in helping people living with kidney disease.”
A randomized multicenter double-blind study tested the efficacy of Farxiga for kidney outcomes. The study included 4,304 patients with CKD divided into a placebo or treatment group. Researchers observed how many patients experienced disease progression of at least a 50% reduction in composite endpoint events including kidney function, progression to kidney failure or cardiovascular or kidney mortality. Of the 2,153 patients on Farxiga, 197 experienced an endpoint event compared with 312 in the placebo group. The treatment arm also experienced less hospitalizations and death compared to the placebo arm.
The study did not investigate the treatment among patients with autosomal dominant or recessive polycystic kidney disease or patients who require or have recently used immunosuppressive therapy for kidney disease.
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