Health Canada has authorized Jardiance® (empagliflozin) to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular and renal death in adults with chronic kidney disease (CKD), Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada Inc. announced. The authorization has the potential to advance the standard of care for more than 4 million people in Canada living with CKD. Along with existing metabolic and cardiovascular indications, Jardiance® can now help manage patients across the spectrum of cardio-renal-metabolic conditions.
One in 10 Canadians are living with kidney disease, and more than 50,000 are being treated for kidney failure symptoms. Diabetes is the leading cause of kidney disease and up to one-half of people living with diabetes develop signs of renal damage in their lifetime.
The authorization by Health Canada is supported by the results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date. Jardiance® 10 mg was superior in reducing the risk of the primary composite endpoint of sustained ≥40% eGFR decline, sustained eGFR <10 mL/min/1.73m², ESKD, renal death or CV death compared with placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.001 [absolute risk reduction 3.8%]). Additionally, Jardiance® 10 mg significantly reduced the risk of all-cause hospitalization, (first and recurrent) by 14% compared with placebo (HR; 0.86; 95% CI 0.78 to 0.95; P=0.003 [absolute risk reduction 4.4%]).
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