Pharma Focus Europe

EU Approves Jardiance® (Empagliflozin) for the Treatment of Chronic Kidney Disease in Adults

Wednesday, July 26, 2023

Boehringer Ingelheim and Eli Lilly jointly announced today that the European Commission (EC) has granted approval for Jardiance® (empagliflozin) to be used in the treatment of adults with chronic kidney disease (CKD). This approval represents a significant milestone in the management of CKD for over 47 million people in the EU. By reducing the risk of all-cause hospitalization in CKD patients, this new treatment option has the potential to relieve the burden on healthcare systems.

In addition to its existing indications for type 2 diabetes and heart failure, empagliflozin has the potential to address cardio-renal-metabolic conditions, which often have interconnected effects. Such conditions are a concern for over 1 billion people worldwide.

Daniel Gallego, President of the European Kidney Patients’ Federation, expressed his appreciation for this milestone, highlighting the importance of early detection and prevention of CKD in the general population. He believes that this new treatment option could significantly improve the management of cardiorenal metabolic syndrome and renal disease, offering hope and an improved quality of life for countless individuals worldwide living with CKD.

The EC's approval is based on the results of the EMPA-KIDNEY trial, which is the largest and most comprehensive study of SGLT2 inhibitors in CKD to date. The trial demonstrated that empagliflozin led to a significant 28 percent reduction in the relative risk of kidney disease progression or cardiovascular death compared to a placebo in people with CKD. Additionally, the trial showed a 14 percent reduction in the relative risk of hospitalization for any cause. The safety profile of empagliflozin was consistent with previous findings.

CKD poses a considerable risk of hospitalization and is a leading cause of death globally. In the EU, hospitalizations account for up to 70 percent of total healthcare costs for CKD patients.

Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim, emphasized the significant impact of CKD on patients and society, given its economic burden on healthcare systems. The approval of empagliflozin represents an essential step in helping patients, physicians, and healthcare systems better manage interconnected cardio-renal-metabolic conditions.

Leonard Glass, M.D., F.A.C.E., Senior Vice President of Diabetes & Obesity Global Medical Affairs at Lilly, highlighted the close relationship between CKD and other cardio-renal-metabolic conditions, such as type 2 diabetes and heart failure. He expressed the companies' commitment to making empagliflozin available to as many people with these conditions as possible and engaging in discussions with regulatory bodies worldwide.

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