The U.S. Food and Drug Administration (FDA) has granted approval for Jardiance (empagliflozin) 10 mg tablets, a significant development announced jointly by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY). This approval pertains to the use of Jardiance in reducing the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) who are susceptible to progression.

It’s crucial to note that Jardiance is not intended for enhancing glycemic control in individuals with type 1 diabetes, as it may heighten the risk of diabetic ketoacidosis in such cases. Additionally, the medication is not recommended for type 2 diabetes patients whose eGFR is below 30 mL/min/1.73 m², as its mechanism of action is unlikely to be effective in this context. Furthermore, Jardiance is not suitable for treating chronic kidney disease in individuals with polycystic kidney disease or those necessitating or having a recent history of intravenous immunosuppressive therapy or receiving more than 45 mg of prednisone or its equivalent for kidney disease.

Mohamed Eid, Vice President of Clinical Development & Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc., emphasized the immense burden that CKD places on both individuals and the healthcare system in the United States. Hospitalizations significantly contribute to the overall healthcare costs for this population, and the progression of the disease often leads to severe cardiovascular complications and kidney failure, necessitating interventions such as dialysis or transplantation. Eid highlighted how the clinically demonstrated benefits of Jardiance provide hope for adults with CKD at risk of progression.

In an extensive clinical trial known as EMPA-KIDNEY, which included over 6,600 patients with CKD with or without type 2 diabetes, Jardiance demonstrated a remarkable 28% relative risk reduction for the composite primary endpoint of kidney disease progression or cardiovascular death compared to a placebo, when used alongside standard care. This significant result reinforces Jardiance’s potential in enhancing patient outcomes and preventing hospitalizations, a crucial secondary endpoint in the study. The safety profile of Jardiance was consistent with its established profile, with no new or unexpected adverse events reported.

This achievement marks the fourth FDA approval for Jardiance arising from the EMPOWER program, demonstrating the commitment of the Boehringer Ingelheim and Lilly Alliance to improving outcomes for individuals living with cardio-renal-metabolic conditions worldwide.

Leonard Glass, Senior Vice President of Diabetes Global Medical Affairs at Lilly, underscored the importance of this FDA approval, as it provides physicians, including nephrologists, with a valuable treatment option for adults at risk of CKD progression. This milestone aligns with Lilly’s global efforts to support the CKD community, following the recent approval of Jardiance for CKD in the EU.

  Boehringer Ingelheim, chronic kidney disease, Eli Lilly and Company, Jardiance, Leonard Glass, Mohamed Eid, US FDA, USA