Healthcare companies Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) revealed on Thursday the receipt of the US Food and Drug Administration's (FDA) Fast Track designation for the investigation of Jardiance (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Chronic kidney disease is associated with an increased risk of premature death from cardiovascular causes and is the ninth leading cause of death in the US.
According to the companies, Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
Under the ongoing global EMPA-KIDNEY clinical study, the partners will randomise about 6,000 participants to receive either Jardiance 10 mg once daily or placebo, each on top of standard of care. The primary outcome is defined as time to a first event of either cardiovascular death or kidney disease progression, defined as end-stage kidney disease.
EMPA-KIDNEY is reportedly being independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), in partnership with the Duke Clinical Research Institute. Boehringer Ingelheim and Lilly are providing the funding for the study.
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