FDA Approves Jardiance (Empagliflozin) for Chronic Kidney Disease in Adults at Risk of Progression

On September 22, Eli Lilly and Boehringer Ingelheim jointly announced that the FDA has approved the SGLT2 inhibitor Jardiance (empagliflozin) tablets for the treatment of adult patients with chronic kidney disease (CKD) who are at risk of progression, to reduce their sustained decline in estimated glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death, and hospitalization risks.

This approval is based on the positive results of the EMPA-KIDNEY study. The study enrolled over 6,600 adult patients with CKD, with or without type 2 diabetes. The results showed that, when added to standard of care, Jardiance reduced the relative risk of the composite primary endpoint of kidney disease progression or cardiovascular death by 28% compared to placebo (absolute risk reduction of 3.6% per patient-year, HR=0.72; 95% CI: 0.64-0.82; P<0.0001). The event rate in the Jardiance group was 13.1% (432/3304) compared to 16.9% (558/3305) in the placebo group.

In addition, compared with placebo, Jardiance significantly reduced the risk of first and recurrent hospitalizations (a pre-specified key secondary endpoint) by 14% (HR=0.86; 95% CI: 0.78-0.95; p=0.0025). In the Jardiance group, 960 patients experienced a total of 1,611 hospitalization events (24.8 events/100 patient-years). In the placebo group, 1,035 patients experienced 1,895 hospitalizations (29.2 events/100 patient-years). The press release noted that EMPA-KIDNEY is the first study to demonstrate that an SGLT2 inhibitor significantly reduces the risk of first and recurrent hospitalizations in CKD patients.

Empagliflozin is a once-daily, highly selective oral SGLT2 inhibitor. To date, the drug has been approved by the FDA for five indications, including the treatment of type 2 diabetes, heart failure with reduced/preserved ejection fraction, cardiovascular risk, and chronic kidney disease. Additionally, to date, empagliflozin has also been approved in China for three indications, including type 2 diabetes and heart failure with reduced/preserved ejection fraction.

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