FDA Approves Jardiance for Patients with Chronic Kidney Disease

The FDA has approved Jardiance (empagliflozin) to treat adults with chronic kidney disease. Jardiance is currently available to treat patients with type 2 diabetes, end stage renal disease and heart failure. Developed by Boehringer Ingelheim and Lilly, Jardiance has a list price of $570.48 for a month supply.

Katherine Tuttle, M.D.

“This approval provides health care professionals in the United States with another treatment option for adults with CKD,” Katherine Tuttle, M.D., executive director for research at Providence Inland Northwest Health, regional principal investigator for the Institute of Translational Health Sciences and professor of medicine at the University of Washington, said in a press release. “The meaningful benefits that empagliflozin demonstrated…are welcome news for adults living with CKD in this country.”

Chronic kidney disease affects more than one in seven adults in the United States, 90% of whom are undiagnosed, and it remains a significantly under-recognized public health crisis, said Mohamed Eid, M.D., vice president of clinical development and medical affairs, cardio-renal-metabolism and respiratory medicine at Boehringer Ingelheim. “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.”

This approval is the fourth FDA nod for Jardiance associated with the EMPOWER clinical trial program. More than 700,000 adults worldwide are enrolled in clinical trials.

EMPA-KIDNEY was placebo-controlled clinical trial of patients with CKD with or without type 2 diabetes. More than 6,600 patients were enrolled. Study results demonstrated that Jardiance was associated with a 28% relative risk reduction vs placebo (absolute risk reduction, 3.6% per patient-year at risk), for the composite primary endpoint of kidney disease progression or cardiovascular death. Event rates were 13.1% and 16.9% for the treatment and placebo groups, respectively.

Notably, the EMPA-KIDNEY trial was the first SGLT2 inhibitor CKD trial “to demonstrate a significant reduction in the risk of first and recurrent hospitalization, a prespecified key secondary endpoint” with a 14% relative risk reduction. Researchers found that in the empagliflozin group, 1,611 hospitalizations occurred among 960 patients — 24.8 events per 100 patient-years — compared with 1,985 hospitalizations among 1035 patients, or 29.2 events per 100 patient-years, in the placebo group.

Reference

US FDA approves Jardiance for the treatment of adults with chronic kidney disease. News release. Eli Lilly and Company. September 22, 2023. Accessed September 22, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-jardiance-for-the-treatment-of-adults-with-chronic-kidney-disease-301936176.html

This story originally appeared on Drug Topics.