FDA Approves Jardiance for Chronic Kidney Disease
Chronic kidney disease is a serious complication for people with diabetes. Recently approved in the U.S., Jardiance (empagliflozin) has been shown to significantly slow down kidney disease and prevent cardiovascular-related death.
Originally approved to lower blood sugar in people with type 2 diabetes, Jardiance is now gaining ground as a treatment for people living with chronic kidney disease (CKD).
The oral medication was recently approved in the U.S. to treat CKD in adults with or without diabetes. Jardiance was previously approved to treat CKD in Europe in July 2023. These approvals were based on significant benefits seen in large research studies.
In the EMPA-KIDNEY clinical trial, participants taking empagliflozin had a 28% lower risk of worsening kidney disease or cardiovascular-related death compared to those taking a placebo. The study also found that the drug reduced the risk of hospitalizations by 14%.
Jardiance joins another SGLT-2 inhibitor approved for CKD in people with or without diabetes, Farxiga (dapagliflozin). In the DAPA-CKD trial, dapagliflozin was shown to reduce the risk of worsening CKD and kidney failure, regardless of diabetes status. Both medications are also approved to reduce the risk of cardiovascular-related hospitalizations and death, with heart attack and stroke being among the leading causes of death in people with diabetes.
Slowing down disease progression is a critical part of treatment since kidney disease often worsens over time. Jardiance not only offers people with kidney disease more treatment options and a better quality of life, but may also help with managing conditions like diabetes, which accounts for roughly 50% of CKD cases.
“This approval provides healthcare professionals in the U.S. with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations," Dr. Katherine Tuttle, Professor of Medicine at the University of Washington and EMPA-KIDNEY steering committee member, said in a press release. “The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase III trial are welcome news for adults living with CKD in this country."
Jardiance was first approved by the U.S. Food and Drug Administration (FDA) in 2014 to treat type 2 diabetes. In June 2023, the FDA approved Jardiance for children 10 years old and up with type 2 diabetes, marking yet another milestone in oral diabetes treatment options for kids.
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