Empagliflozin is approved to lower the risk of sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with CKD at risk of progression.
The US Food and Drug Administration (FDA) today approved empagliflozin (Jardiance®; Eli Lilly and Company) 10 mg tablets to lower the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.
“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 at Lilly, said in a press release from Boehringer Ingelheim Pharmaceuticals, and Eli Lilly and Company.
The FDA’s decision was based on results of the EMPA-KIDNEY phase 3 trial—a multinational, randomized, double-blind, placebo-controlled clinical study—designed to assess the effects of the sodium glucose cotransporter-2 (SGLT-2) inhibitor in adults at risk of CKD progression. The trial included 6609 adults (with or without diabetes) with CKD. Patients had an eGFR of at least 20 mL/min/1.73 m2 but less than 45 mL/min/1.73 m2, or 45 mL/min/1.73 m2 but less than 90 mL/min/1.73 m2 with a urine albumin-to-creatinine ratio of at least 200 mg/g.
Results showed that during a median follow-up of 2 years, empagliflozin demonstrated a 28% relative risk reduction for the composite primary endpoint of kidney disease progression or cardiovascular death compared to placebo when administered in addition to standard care.
EMPA-KIDNEY also was the first trial of an SGLT-2 inhibitor for the treatment of CKD that showed a significant relative risk reduction for first and recurrent hospitalization (14%) vs placebo, a prespecified secondary endpoint for the trial, according to the release.
"This approval provides healthcare professionals in the U.S. with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations," said Katherine Tuttle, MD, executive director for research, Providence Inland Northwest Health, regional principal investigator for the Institute of Translational Health Sciences and Professor of Medicine at the University of Washington, and EMPA-KIDNEY steering committee member, in the press release. "The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase III trial are welcome news for adults living with CKD in this country."
“Hospitalizations account for a third to a half of total health care costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation,” said Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs at Boehringer Ingelheim, in the release. “Given the clinically demonstrated benefits of Jardiance, we are proud to now be able to offer this option to adults with CKD at risk for progression.”
Empagliflozin 10 mg is not recommended for use to improve glycemic control in patients with type 1 diabetes, according to the press release, as it may increase their risk of diabetic ketoacidosis. In addition, empagliflozin 10 mg is not recommended for use to improve glycemic control in patients with type 2 diabetes with an eGFR of less than 30 mL/min/1.73 m2, nor is it recommended for the treatment of CKD in patients with polycystic kidney disease or for persons requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease, according to the release.