The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for empagliflozin to reduce the risk of kidney disease progression and cardiovascular (CV) death in adults with chronic kidney disease (CKD).
The application is supported by data from the phase 3 EMPA-KIDNEY trial (ClinicalTrials.gov Identifier: NCT03594110), which enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes. The study population included patients with or without diabetes, with mildly to severely reduced eGFR, and with normal and increased levels of albumin. Patients were randomly assigned to receive empagliflozin 10mg or placebo once daily, in addition to standard of care.
Findings showed that treatment with empagliflozin met the primary endpoint reducing the risk of kidney disease progression or CV death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.64-0.82; P <.001). Empagliflozin was also associated with a 14% reduction in the risk of hospitalization for any cause compared with placebo (HR, 0.86; 95% CI, 0.78-0.95; P =.003).
“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “This application acceptance is an important step forward for the approximately 37 million people in the US living with CKD.”
Empagliflozin is marketed under the brand name Jardiance® and is currently indicated to improve glycemic control as an adjunct to diet and exercise in adults with type 2 diabetes mellitus (T2DM); to reduce the risk of CV death in adults with T2DM and established CV disease; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction.
- US FDA accepts supplemental New Drug Application for Jardiance® for adults with chronic kidney disease. News release. Eli Lilly and Company. Accessed January 20, 2023. https://www.prnewswire.com/news-releases/us-fda-accepts-supplemental-new-drug-application-for-jardiance-for-adults-with-chronic-kidney-disease-301726873.html.
- The EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. Published online January 12, 2023. NEJM. doi:10.1056/NEJMoa2204233