FDA Accepts Jardiance sNDA for CKD Indication

A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.

The FDA has accepted a supplemental new drug application (sNDA) for Jardiance (empagliflozin), which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). An FDA decision is in the second half of 2023.

Developed by Boehringer Ingelheim and Eli Lilly, Jardiance is an oral SGLT2 inhibitor used to lower blood sugar in adults with type 2 diabetes, as well as to reduce the risk of cardiovascular death for those with type 2 diabetes and those with cardiovascular disease. The current list price for a month supply of Jardiance is $570.48. The company offers a copay savings card for those with commercial insurance and also provides assistance for those without insurance.

“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” Mohamed Eid, M.D., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, said in a press release.

The application is based on results from the landmark EMPA-KIDNEY phase 3 trial, in which Jardiance significantly reduced the risk of kidney disease progression or cardiovascular death in adults with CKD by 28% compared with placebo. Results were presented during the American Society of Nephrology’s Kidney Week 2022 and simultaneously published in The New England Journal of Medicine.

The trial showed a significant reduction in risk of hospitalization for any cause, with a 14% relative risk reduction with Jardiance versus placebo in a pre-specified key secondary endpoint. Reductions in other key secondary endpoints of hospitalization for heart failure or cardiovascular death or all-cause death were not statistically significant. Hospitalizations account for 35% to 55% of total healthcare costs for people with CKD in the United States.