SGLT2 Inhibitor Empagliflozin Approved in China for Adult Chronic Kidney Disease

On November 24, Boehringer Ingelheim and Eli Lilly and Company jointly announced that a new indication for their SGLT2 inhibitor Jardiance® (empagliflozin) under the diabetes alliance has been approved by the China National Medical Products Administration for the treatment of chronic kidney disease (CKD) in adults.

This is another new indication for Jardiance® approved in China, following adult type 2 diabetes, heart failure with reduced ejection fraction in adults, heart failure with preserved ejection fraction in adults, and combination insulin therapy for type 2 diabetes. Together with the existing indications for type 2 diabetes and heart failure, Jardiance® helps manage risks associated with cardio-renal-metabolic diseases. Since its market launch, it has benefited more than 1 billion patients globally.

CKD is usually characterized by a progressive decline, marked by a decrease in estimated glomerular filtration rate (eGFR) and high albuminuria. Due to the insidious onset of CKD, the rates of early diagnosis and treatment are low. Once CKD patients progress to end-stage kidney disease (ESKD), renal replacement therapy (including hemodialysis, peritoneal dialysis, or kidney transplantation) is required to sustain life. Results from the sixth China Chronic Disease and Risk Factors Surveillance show that there are currently about 82 million adult CKD patients in China, with a CKD prevalence rate of 8.2%.

The approval of empagliflozin for this indication is based on the EMPA-KIDNEY clinical trial. The trial results showed that, compared with the placebo group, empagliflozin treatment reduced the relative risk of kidney disease progression or cardiovascular death in CKD patients by 28%, and reduced the relative risk of hospitalization for any cause by 14%, which was statistically significant (HR: 0.86; 95% CI 0.78-0.95; P=0.0025 [absolute risk reduction 4.4%]). The trial demonstrated that the overall safety data were generally consistent with previous study results, confirming the safety of empagliflozin. Moreover, the effect of empagliflozin on CKD treatment was independent of the patient's diabetes status and was effective for patients with eGFR across different ranges.