(HealthDay) – Oral Farxiga (dapagliflozin) tablets are now approved for use in adults with chronic kidney disease who are at risk of the disease getting worse, the US Food and Drug Administration said on Friday.
The drug is the first to be approved to reduce the risk of many causes of illness, including renal impairment, kidney failure, cardiovascular death, and hospitalization for heart failure. Farxiga was first approved in 2014 to improve blood sugar control in adults with type 2 diabetes.
The approval was based on efficacy data from the DAPA-CKD Phase III study, a multicenter, double-blind study with 4,304 patients who were randomly assigned to the standard of care plus Farxiga 10 mg or placebo. Patients were evaluated for progression to a composite endpoint of ≥ 50 percent reduction in renal function, progression to renal failure, or cardiovascular or kidney death. At least one composite endpoint occurred in 197 of 2,152 patients who received Farxiga compared with 312 of 2,152 patients who received placebo – a reduction of 39 percent. 100 patients who received Farxiga were hospitalized for heart failure or death, while 138 patients received placebo.
The FDA notes that Farxiga is not indicated for patients with autosomal dominant or recessive polycystic kidney disease, or for patients on immunosuppressive therapy to treat kidney disease. There have been reports of serious, life-threatening cases of Fournier’s gangrene in patients with diabetes taking Farxiga. It can also cause dehydration, severe urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis. Physicians should evaluate the patient’s volume status and kidney function before starting Farxiga.
Approval was given to AstraZeneca.
The FDA approves Farxiga for heart failure with reduced ejection fraction
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