SILBERFEDER, Md., April 30, 2021 / PRNewswire / – The U.S. Food and Drug Administration today approved oral Farxiga (dapagliflozin) tablets to reduce the risk of deterioration in kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease Disease progression.
“Chronic kidney disease is a major public health issue and there is a significant unmet need for therapies that will slow disease progression and improve outcomes,” he said Aliza Thompson, MD, MS, assistant director of the Department of Cardiology and Nephrology at the FDA Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people with kidney disease.”
Chronic kidney disease occurs when the kidneys are damaged and cannot filter the blood normally. Because of this inadequate filtration, patients can experience complications related to fluids, electrolytes (minerals used in many body processes), and waste build-up in the body. Chronic kidney disease can sometimes lead to kidney failure. Patients are also at high risk for cardiovascular disease, including heart disease and stroke.
The effectiveness of Farxiga in improving kidney outcomes and reducing cardiovascular death in patients with chronic kidney disease was evaluated in a multicenter, double-blind study. In this study, 4,304 patients were randomly assigned to receive either Farxiga or a placebo. The study compared the two groups in terms of the number of patients whose disease progressed to a composite (or composite) endpoint that included at least a 50% decrease in kidney function, progression of kidney failure, or cardiovascular or kidney death . The results showed that 197 of the 2,152 patients who received Farxiga had at least one of the composite endpoint events, compared with 312 of the 2,152 patients who received a placebo. The study also compared the two groups in terms of the number of patients hospitalized for heart failure or dying of cardiovascular disease. A total of 100 patients who received Farxiga were hospitalized or died compared to 138 patients who received a placebo.
Farxiga has not been studied or considered effective in the treatment of chronic kidney disease in patients with autosomal dominant or recessive polycystic kidney disease (characterized by multiple cysts) or in patients who are in need of, or have recently used, immunosuppressive therapy to treat kidney disease.
Patients should not use Farxiga if they have had a history of severe hypersensitivity reactions to the drug or if they are receiving dialysis treatment. Serious, life-threatening cases of Fournier’s gangrene have occurred in diabetic patients taking Farxiga. Patients should consider a lower dose of insulin or an insulin secretagogue to reduce the risk of hypoglycaemia (low blood sugar) while also taking Farxiga. Farxiga can cause dehydration, severe urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis (acid buildup in the blood). Patients should be assessed for volume status and renal function before starting Farxiga treatment.
Farxiga was originally approved in 2014 to improve blood sugar control in adults with type 2 diabetes in addition to diet and exercise.
Farxiga has been named Fast Track, Breakthrough Therapy and Priority Review for the indication approved today. Fast Track is designed to facilitate development and expedite drug review to treat serious medical conditions and meet an unmet medical need. The name for a breakthrough therapy is intended to accelerate the development and review of drugs that are used to treat a serious medical condition. Preliminary clinical evidence suggests that the drug may show substantial improvement over available therapy at a clinically significant endpoint. The priority review draws general attention and resources to the evaluation of drug submissions, the approval of which, compared to standard submissions, would significantly improve the safety or effectiveness of the treatment, diagnosis or prevention of serious diseases.
The FDA approved Farxiga for AstraZeneca.
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Source US Food and Drug Administration