The FDA has finally approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for the treatment of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
Dapagliflozin was first approved by the FDA in 2014 to boost blood sugar control in adults with type 2 diabetes in addition to diet and exercise.
The agency has granted the approval of Farxiga to AstraZeneca.
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“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, M.D., M.S., deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research said.
“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 most common causes of chronic kidney disease (CKD) are diabetes, hypertension, and glomerulonephritis. In its most severe form, known as end-stage kidney disease (ESKD), kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required.
Farxiga improves kidney outcomes and reduces cardiovascular death in patients with CKD was evaluated in a multicenter, double-blind study.
In the study, 4,304 patients were randomly assigned to receive either Farxiga or a placebo. The study compared the two 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 2,152 patients who received Farxiga had at least one of the composite endpoint events compared to 312 of the 2,152 patients who received a placebo. The study also compared the two groups for the number of patients who were hospitalized for heart failure or died from cardiovascular disease. A total of 100 patients who received Farxiga were hospitalized or died compared to 138 patients who received a placebo.
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 need or have recently used immunosuppressive therapy to treat kidney disease.
Patients, who have a history of serious hypersensitivity reactions to the medication or if they are on dialysis treatment, should not use Farxiga. Serious, life-threatening cases of Fournier’s Gangrene have been observed in patients with diabetes taking Farxiga.
Patients should consider a lower dose of insulin or insulin secretagogue to reduce the risk of hypoglycemia (low blood sugar) if they are also taking Farxiga.
Farxiga can cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis.
Patients should be assessed for their volume status and kidney function before starting Farxiga.