More therapy options are needed to help reduce the risk of chronic kidney disease (CKD) progression. Fortunately, the U.S. Food and Drug Administration (FDA) has recently accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets to treat CKD. Learn what research has shown so far about the benefits of the medication and what the FDA status is for approval in prescribing it to CKD patients.* 

What is Jardiance® currently prescribed for?

Since 2014, Jardiance® has been used, alongside diet and exercise, to lower blood sugars in adults with type 2 diabetes. For these patients, it also reduces the risk of cardiovascular (heart) death, and hospitalization for patients with heart failure. It is currently not recommended for type 2 diabetes patients with an estimated glomerular filtration rate (kidney function) of less than 30 mL/min/1.73 m2.

What happened in the EMPA-KIDNEY phase III trial?  

The EMPA-KIDNEY phase III clinical trial enrolled 6,609 participants with various causes of CKD, including people without diabetes (56%). Participants spanned the spectrum of kidney function measurements (eGFR) and amounts of albumin (protein) in their urine. 

Researchers analyzed the effects of Jardiance® on participants compared to the effects of a placebo. They found a 28% reduction in the risk of CKD progression or cardiovascular death compared to a placebo, both on top of standard care. They also found a significant reduction in the risk of hospitalization for any cause in participants taking Jardiance®. 

What is the FDA doing now? 

Given the findings, and further investigation, the FDA accepted a supplemental New Drug Application (sNDA) for Jardiance®. If approved, this will allow the use of Jardiance® to expand to CKD patients. 

“This marks another exciting milestone for Jardiance®, potentially extending its ability to positively impact the approximately one billion people diagnosed with a cardio, renal, or metabolic condition,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly, the drug’s manufacturer. “We look forward to working with the FDA during the review process, and eagerly await a decision later this year on the indication for CKD, which doubles a person’s risk for hospitalization.”

*US FDA accepts supplemental New Drug Application for Jardiance® for adults with chronic kidney disease. (2023, January 20). Lilly Investors. Retrieved January 23, 2023, from https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-0