A New Rx for Chronic Kidney Disease

The US Food and Drug Administration (FDA) has approved a new medication to treat chronic kidney disease.

The FDA approved Farxiga (dapagliflozin) for use in adults with kidney disease that could progress. The drug is meant to reduce the risk of kidney failure, declines in kidney function, hospitalization for heart failure and cardiovascular death.

“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 Dr. Aliza Thompson, deputy director of the FDA's Division of Cardiology and Nephrology, in a press release. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

When the kidneys are unable to filter blood normally, chronic kidney disease can occur. Chronic kidney disease can cause issues with the buildup of waste in the body, as well as problems with fluids and electrolytes. This disease can progress to kidney failure.

Patients with chronic kidney disease also face a high risk of cardiovascular problems like strokes and heart attacks.

Farxiga is meant to slow or stop these issues tied to chronic kidney disease. The FDA approved this drug based on the results of a trial of 4,304 patients with chronic kidney disease. Some patients received Farxiga, while others received a placebo.

Patients who received Farxiga were much less likely to experience severe kidney function decline, kidney failure, or death related to kidney or heart issues.

The FDA noted that Farxiga was not studied for treatment of chronic kidney disease in patients with autosomal dominant or recessive polycystic disease or those who have recently used immunosuppressive therapy for their kidney disease. The agency also said this drug is not expected to work well in those applications.

Patients who are on dialysis or who have a history of sensitivity to Farxiga should not take this medication, the FDA said. The agency also noted that severe cases of Fournier’s Gangrene have occurred in patients who have diabetes and take this drug. Potential side effects of Farxiga include metabolic acidosis or ketoacidosis, genital yeast infections, serious urinary tract infections and dehydration.

Talk to your health care provider about risks and benefits before taking any new medication.

The FDA approved Farxiga for AstraZeneca.