The approval has been granted for Jardiance 10mg tablets for to reduce the sustained risk of decline in the estimated glomerular filtration rate (eGFR), end-stage disease, cardiovascular death and hospitalisation in adult patients with CKD at risk of progression.
The effect of Jardiance on kidney disease progression and cardiovascular mortality risk was assessed in the EMPA-KIDNEY randomised placebo-controlled, double-blind, multinational and placebo-controlled clinical study.
EMPA-KIDNEY comprised 6,609 adults with CKD from eight countries, including individuals both with and without diabetes. They were randomised and given either Jardiance 10mg or a placebo once a day, in addition to the ongoing standard of care.
Jardiance showed a 28% reduction in relative risk compared to placebo.
The reduction was observed in the composite primary endpoint of kidney disease progression or cardiovascular death.
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This was the first SGLT2 inhibitor CKD study to show a reduction in the risk of first and recurrent hospitalisation, a pre-specified secondary endpoint, with a 14% relative risk reduction against placebo.
Lilly Diabetes global medical affairs senior vice-president Leonard Glass stated: “Following previous indications for Jardiance in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression.
“Alongside the recent CKD approval for Jardiance in the EU, this decision further bolsters our efforts to support this community globally.”