The Food and Drug Administration on Friday approved oral dapagliflozin (Farxiga) tablets to slow the progression of chronic kidney disease in adults with and without type 2 diabetes.
Farxiga, an SGLT2 inhibitor, was found to reduce the risk of worsening kidney function or cardiovascular or renal death by 39% compared to placebo in patients with stage 2 to 4 chronic kidney disease and high urinary albumin levels. The same results have been seen in patients with and without type 2 diabetes, drug maker AstraZeneca also reported on Friday.
The drug was first approved in 2014 to help improve blood sugar control in type 2 diabetes along with diet and exercise. It was approved for the treatment of heart failure in May 2020.
Farxiga is not expected to be effective in the treatment of autosomal dominant or recessive polycystic kidney disease or in patients who are in need of or have recently used immunosuppressive therapy to treat kidney disease, according to the FDA. It should not be used by dialysis patients and may require changes in insulin dosages to reduce the risk of low blood sugar, the agency said.
Possible side effects include dehydration, severe urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis (acid buildup in the blood), the FDA added.
According to FiercePharma, Johnson & Johnson’s SGLT2 drug Invokana is also approved for the treatment of diabetic kidney disease, but not in patients with kidney disease without diabetes. Eli Lilly and Boehringer Ingelheim also have a competing SGLT2 drug called Jardiance, but data from the study on kidney disease outcomes is not expected until 2022, the news agency reported.
Chronic kidney disease is a progressive disease typically caused by diabetes, high blood pressure, and immune disorders that result in decreased kidney function.
Subjects:
AstraZeneca Chronic Kidney Disease Clinical Diabetes Care Food and Drug Administration Kidney Disease Kidney Disease Type 2 Diabetes
