Empagliflozin gains US FDA approval for the treatment of adults with chronic kidney disease


The US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease (CKD) at risk of progression, Boehringer Ingelheim and Eli Lilly and Company have announced.

“This approval provides healthcare professionals in the USA with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalisations,” said Katherine Tuttle (Providence Inland Northwest Health, Spokane, USA), 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.”

“Following previous indications for Jardiance in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression,” said Leonard Glass, senior vice president, Diabetes Global Medical Affairs, Lilly. “Alongside the recent CKD approval for Jardiance in the EU, this decision further bolsters our efforts to support this community globally.”


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