Eli Lilly & Boehringer Ingelheim Announce US FDA Nods Jardiance To Treat Adults with Chronic Kidney Ailments

Jardiance (empagliflozin) 10 mg tablets have been approved by the US Food and Drug Administration (FDA) to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR) end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney ailment (CKD) at risk of progression. Jardiance is not indicated for use in people with type 1 diabetes to enhance glycemic control.

In these patients, it may raise the risk of diabetic ketoacidosis. Jardiance is not advised for usage in people with type 2 diabetes who have an eGFR less than 30 mL/min/1.73 m2. Based on its method of action, Jardiance is unlikely to be effective in this situation. Jardiance is not advised for the treatment of chronic kidney disease in patients with polycystic kidney disease, patients requiring or having a recent history of intravenous immunosuppressive medication, or patients requiring or having a recent history of prednisone or equivalent for kidney disease in doses greater than 45 mg. Jardiance will not be effective in these populations.

Jardiance is not indicated for use in people with type 1 diabetes to enhance glycemic control. In these patients, it may raise the risk of diabetic ketoacidosis. Jardiance is not advised for usage in people with type 2 diabetes who have an eGFR less than 30 mL/min/1.73 m2. Based on its method of action, Jardiance is unlikely to be effective in this situation. Jardiance is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.

Jardiance is not expected to be effective in these populations, as per Indianapolis. "This approval provides healthcare professionals in the US with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations," said Katherine Tuttle, M.D., executive director for research, Providence Inland Northwest Health, Regional Principal investigator for the Institute of Translational Health Sciences and Professor of Medicine at the University of Washington, and EMPA-KIDNEY steering committee member. "The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase III trial are welcome news for adults living with CKD in this country."