The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment.
Boehringer Ingelheim co-developed empagliflozin with Lilly.
The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD).
The committee recommended that the Phase 3 study be stopped early, given clearly positive data.
Earlier, the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), concluded Jardiance met the prespecified positive efficacy criteria.
Jardiance was first FDA approved as a treatment for type 2 diabetes in 2014. An indication followed for reducing the risk of cardiovascular death in adults with type 2 diabetes in 2016.
Approvals followed in 2021 and 2022 for heart failure with reduced ejection fraction and heart failure regardless of left ventricular ejection fraction in 2021 and February 2022, respectively.
Jardiance is a sodium-glucose transporter 2 inhibitor (SGLT2).
The double-blind, randomized, placebo-controlled EMPA-KIDNEY trial is the largest SGLT2 inhibitor trial in CKD performed thus far, enrolling 6,600 adults.
“We studied a wide range of patients with declining kidney function with the aim of delaying the need for dialysis and avoiding heart disease in as many of them as possible,” said associate professor William Herrington at Oxford Population Health.
The composite primary outcome of the study was the time to the first occurrence of kidney disease progression or cardiovascular death.