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The Farxiga (Dapagliflozin) has approved to treat chronic kidney disease by the U.S. Food and Drug Administration (FDA) on 30 May 2021. The oral tablet has been approved to reduce the risk of kidney failure, cardiovascular death, and heart failure in the adult with chronic kidney diseases.
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, “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”. She also added, “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
As per the latest information shared by the Centers for Disease Control and Prevention (CDC), around 37 million adults are accounted to have chronic kidney diseases in the United States and most are undiagnosed. Kidney diseases are the ninth leading cause of death in the United States. Furthermore, CDC also cited, high blood pressure and diabetes are the leading causes of kidney failure, representing 3 out of 4 new cases.
To improve glycemic control with diabetes mellitus in patients, the drug was approved in 2014, and based on the results of the DAPA-HF trial, in 2020, it included treatment of patients with heart failure and reduced ejection fraction. This new approval in chronic kidney disease was based on the results of the DAPA-CKD trial which was halted in early March 2020 due to the efficacy of the treatment.
DAPA-CKD randomly assigned 4304 patients with CKD, but without diabetes to receive either dapagliflozin or placebo. The results of the full study, reported at the European Society of Cardiology Congress in 2020 as well as published in the New England Journal of Medicine, showed that, during the median age of 2.4 years, treatment with dapagliflozin caused 31% of relatives Compared with placebo. In the primary outcome of the study, a composite that included at least a 50% drop in estimated glomerular filtration rate with baseline, end-stage renal disease, kidney transplant, renal death, or cardiac death.
Dapagliflozin treatment cut all-cause mortality by a statistically significant relative decrease of 31%, and another secondary-endpoint analysis represents a statistically significant 29% relative decrease in the rate of cardiac death or heart failure.
“Farxiga was not studied, nor expected to be effective, to treat chronic kidney disease among renal patients with autosomal dominant or recurrent polycystic (characterized by multiple ulcers), or among patients who have recently required immunosuppressive therapy to treat kidney disease in children, notes the FDA statement.
Patients should consider taking low doses of insulin or insulin secretion to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, severe urinary tract infection, genital yeast infection, and metabolic acidosis, the announcement said. The agency stated, “Patients should be evaluated for their volume status and renal function before starting Pharxiga”.
