Empagliflozin has been granted an additional indication by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic kidney disease (CKD). According to the agency’s approval, the popular SGLT2 inhibitor is associated with a reduced risk of CKD progression and cardiovascular death in adult patients.
Empagliflozin, sold by Boehringer Ingelheim and Eli Lilly and Company under the name Jardiance, has already been approved by the FDA to treat type 2 diabetes and heart failure.
This latest approval from the FDA was largely based on data from the EMPA-KIDNEY trial, which examined the drug’s effectiveness among more than 6,500 patients with and without type 2 diabetes. Overall, empagliflozin was associated with a 28% relative risk reduction for the composite endpoint of CKD progression or cardiovascular death when compared to a placebo. It was also linked to a reduced risk of all-cause hospitalization.
“Following previous indications for Jardiance in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression,” Leonard Glass, MD, senior vice president of Diabetes Global Medical Affairs for Eli Lilly, said in a prepared statement.
“CKD affects more than one in seven adults in the U.S., 90% of whom are undiagnosed, and it remains a significantly underrecognized public health crisis,” added Mohamed Eid, MD, MPH, vice president of clinical development and medical affairs for the Cardio-Renal-Metabolism and Respiratory Medicine Division at Boehringer Ingelheim Pharmaceuticals. “Hospitalizations account for a third to a half of total healthcare costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation.”
Empagliflozin is not recommended for patients with type 1 diabetes; it may heighten the risk of diabetic ketoacidosis. It is also not recommended for the treatment of CKD in patients with polycystic kidney disease.
Additional details on the EMPA-KIDNEY trial
All patients included in the EMPA-KIDNEY trial presented with an eGFR ≥20 to <45 mL/min/1.73 m2 or an eGFR ≥45 to <90 mL/min/1.73 m2 with a urine albumin to creatinine ratio ≥200 mg/g. Patients were excluded from the trial if presenting with type 2 diabetes and prior atherosclerotic cardiovascular disease with an eGFR lower than 60 mL/min/1.73 m2. Additional exclusions were made for patients with type 1 diabetes, polycystic kidney disease or a recent history of intravenous immunosuppressive therapy or treatment with ≥ 45 mg of prednisone.
The full study was published in the New England Journal of Medicine.[1]
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