Serious and progressive kidney disease affects approximately 850 million people worldwide.
The Scottish Medicines Consortium (SMC) has approved Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for use within NHS Scotland for the treatment of adult patients with chronic kidney disease (CKD).
Regulators have indicated the treatment is intended for adult CKD patients who are receiving optimized standard therapy, including an angiotensin-converting enzyme inhibitor or an angiotensin 2 receptor antagonist, and who have an estimated glomerular filtration rate (eGFR) between 20 ml/min/1.73 m2 and 45 ml/min/1.73 m2, or an eGFR between 45 ml/min/1.73 m2 and 90 ml/min/1.73 m2.
In addition, patients in the 45ml to 80ml group in Scotland can now receive Jardiance if they have a urinary albumin/creatine ratio of 22.6mg/mmol or above or type 2 diabetes (T2D).
CKD is a serious, progressive disease that affects approximately 850 million people worldwide and is caused by a decline in kidney function, often due to diabetes, hypertension, and glomerulonephritis.
Jardiance, already approved in the EU and the US, is a highly selective, oral, once-daily sodium-glucose cotransporter 2 inhibitor and the first type 2 diabetes treatment to be labelled for cardiovascular death risk reduction in multiple countries.
SMC’s decision was based on results from the randomized, double-blind Phase 3 EMPA-KIDNEY trial, which evaluated Jardiance in patients with CKD in addition to standard of care.
Published in New England Journal of MedicineResults showed that giving Jardiance in addition to standard of care significantly reduced the risk of first-time kidney disease progression or cardiovascular death compared with standard of care alone.
In March 2022, the companies announced they would stop the Phase 3 trial early due to apparently positive efficacy results in CKD patients.
“Stopping the trial early marks a major step toward our goal of improving the lives of adults with kidney disease,” Jeff Emmick, Lilly’s vice president of product development, said at the time.
