FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment
Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10mg tablets to reduce 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).
This approval follows data from the EMPA-KIDNEY trial, which included over 6,600 patients with CKD. In this trial, Jardiance demonstrated a 28% relative risk reduction compared to placebo, both on top of standard care, for the composite primary endpoint of kidney disease progression or cardiovascular death.
Mohamed Eid, MD MPH MHA, vice president of Clinical Development and Medical Affairs, Cardio-Renal-Metabolism and Respiratory Medicine at Boehringer Ingelheim Pharmaceuticals, commented: “CKD affects more than one in seven adults in the US, 90% of whom are undiagnosed, and it remains a significantly under-recognised public health crisis. Hospitalisations account for a third to a half of total healthcare costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation. Given the clinically demonstrated benefits of Jardiance, we are proud to now be able to offer this option to adults with CKD at risk for progression.”
Leonard Glass, MD FACE, senior vice president of Diabetes Global Medical Affairs at Eli Lilly, added: “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. 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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