Eli Lilly and Boehringer Ingelheim’s Jardiance approved by FDA for treatment of chronic kidney disease

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.”
Katherine Tuttle MD, 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, stated: “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 hospitalisations. The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase 3 trial are welcome news for adults living with CKD in this country.”