SMC accepts Boehringer/Lilly’s Jardiance for CKD within NHS Scotland

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The serious, progressive kidney disease affects nearly 850 million people worldwide

The Scottish Medicines Consortium (SMC) has accepted Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for use within NHS Scotland to treat adult patients living with chronic kidney disease (CKD).

The regulator has indicated the therapy for adult CKD patients who are receiving optimised standard care, including angiotensin converting enzyme inhibitors or angiotensin 2 receptor blockers, with either an estimated glomerular filtration rate (eGFR) of 20ml/min/1.73m2 up to 45ml/min/1.73m2 or an eGFR of 45ml/min/1.73m2 up to 90ml/min/1.73m2.

Additionally , patients in Scotland in the 45ml to 80ml group will now be eligible to receive Jardiance if they have a urine albumin-to-creatine ratio of 22.6mg/mmol or more or type 2 diabetes (T2D) mellitus.

Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition that is caused by decreased kidney function and is often triggered by diabetes, hypertension and glomerulonephritis.

Already approved in the EU and US, Jardiance is an oral, once-daily, highly selective sodium-glucose cotransporter 2 inhibitor and is the first ever T2D medicine to include cardiovascular death risk reduction in its label across several countries.

The SMC’s decision was based on results from the randomised, double-blind phase 3 EMPA-KIDNEY study, which assessed Jardiance in patients with CKD in addition to standard of care.

Published in the New England Journal of Medicine, results showed that treatment with Jardiance in addition to standard of care significantly reduced the risk of first occurrence of the progression of kidney disease or death from cardiovascular causes compared to standard of care alone.

In March 2022, the companies announced that the phase 3 study would stop early due to clear positive efficacy results in people with CKD.

Commenting at the time, Jeff Emmick, vice president, product development, Lilly, said: “The early stop of the trial is a tremendous step toward our goal of improving the lives of adults living with kidney disease.”

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