FDA expanded the indication for dapagliflozin (Farxiga) into chronic kidney disease (CKD).
The drug, which first entered the market for type 2 diabetes in 2014, was approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of progression.
CKD has “a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the Division of Cardiology and Nephrology at the FDA’s Center for Drug Evaluation and Research, 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.”
Approval centered on the DAPA-CKD trial. In that trial, the SGLT2 drug reduced by a relative 39% worsening kidney function or death due to kidney disease or cardiovascular disease over a median 2.4 years. All-cause mortality also fell by a relative 31% with dapagliflozin compared with placebo. Effects were similar among participants with and without type 2 diabetes.
In a statement from drugmaker AstraZeneca, DAPA-CKD investigator Hiddo Heerspink, PhD, PharmD, of University Medical Center Groningen in the Netherlands, called the approval a “transformational milestone” that provides physicians with an effective new option for CKD patients, regardless of type 2 diabetes status.
However, FDA cautioned that this drug isn’t for patients on dialysis. In addition, “Farxiga was not studied, nor is expected to be effective, in treating CKD among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the agency’s approval notice pointed out.
For people with diabetes, FDA suggested considering a lower dose of insulin or insulin secretagogue while taking dapagliflozin to reduce the risk of hypoglycemia. This group has also seen serious, life-threatening cases of Fournier’s gangrene while on the SGLT2 inhibitor.
Other risks for all patients include dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis. FDA noted that physicians should assess volume status and kidney function before starting patients on dapagliflozin.
Dapagliflozin was also approved in 2019 to reduce heart failure hospitalization risk in adults with type 2 diabetes at elevated risk due to established cardiovascular disease or multiple risk factors for it, and in 2020 to treat heart failure with reduced ejection fraction.