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# FDA OKs Jardiance in Chronic Kidney Disease
- URL: https://www.fdaweb.com/fda-oks-jardiance-in-chronic-kidney-disease/
- Published: 2023-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:57:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155400

FDA has approved Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.

Approval was based on data from the EMPA-KIDNEY trial that demonstrated Jardiance had a 28% relative risk reduction compared with placebo for the composite primary endpoint of kidney disease progression or cardiovascular death. The event rate for Jardiance was 13.1% compared with 16.9% for placebo. “EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to demonstrate a significant reduction in the risk of first and recurrent hospitalization, a pre-specified key secondary endpoint, with a 14% relative risk reduction (HR=0.86; 95% CI 0.78 to 0.95; p=0.0025) with Jardiance versus placebo,” the companies say. “In the Jardiance group, 1,611 hospitalizations occurred among 960 patients (24.8 events per 100 patient-years). In the placebo group, 1,895 hospitalizations occurred among 1,035 patients (29.2 events per 100 patient-years).”

Jardiance was previously approved for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body. It is also approved for the following indications:

- reducing the risk of further worsening of kidney disease, end-stage kidney disease), death due to cardiovascular disease, and hospitalization in adults with chronic kidney disease
- reducing the risk of cardiovascular death in adults with Type 2 diabetes who also have known cardiovascular disease
- lowering blood sugar along with diet and exercise in adults and children who are 10 years of age and older with Type 2 diabetes