The FDA approves Dapagliflozin (Farxiga) for chronic kidney disease


The U.S. Food and Drug Administration has approved it dapagliflozin (Happiness, AstraZeneca) to reduce the risk of decreased function, renal failure, cardiovascular death and hospitalization for heart attack in adult patients with chronic kidney disease at risk of disease progression.

“Chronic kidney disease is a major public health problem and there is a significant unmet need for therapies that slow the progression of the disease and improve outcomes,” said Aliza Thompson, MD, deputy director of the Division of Cardiology and Nephrology. of the FDA Drug Evaluation and Research Center. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus and was approved expanded in 2020 include the treatment of patients with heart failure and reduced ejection fraction, based on the results of the DAPA-HF test.

This new approval in chronic kidney disease was based on the results of the DAPA-CKD judgment that was he stopped early in March 2020 due to treatment effectiveness.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive dapagliflozin or placebo. The results of the full study were reported to the Congress of the European Society of Cardiology in 2020 and simultaneously published at the New England Journal of Medicine, showed that over a median of 2.4 years, dapagliflozin treatment resulted in a significant relative reduction of 31% compared with placebo in the primary endpoint of the study, a compound that included at least a 50% drop in the estimated rate of glomerular filtration (eGFR) compared with basal, end-stage renal disease, kidney transplantation, kidney death, or cardiovascular death.

Dapagliflozin treatment also reduced all-cause mortality through a statistically significant relative reduction of 31%, and another secondary endpoint analysis showed a statistically significant relative reduction of 29% in the rate of cardiovascular death or hospitalization for heart failure.

“Farxiga has not been studied or expected to be 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 need or have recently used immunosuppressive therapy to treat kidney disease, “the FDA said.

Dapagliflozin should not be used in patients with a history of severe hypersensitivity reactions to this medicine or who are on dialysis, the agency added. “Serious cases that endanger the lives of Fournier’s gangrene have occurred in diabetic patients taking Farxiga, ”he notes.

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they also take dapagliflozin. Treatment can also cause dehydration, severe urinary tract infections, genital yeast infections, and metabolic acidosis, according to the ad. “Patients should be assessed for volume status and kidney function before starting Farxiga,” the agency adds.

Farxiga previously received Fast track, Advanced therapy i Priority review designations for this new indication.

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