Boehringer, Eli Lilly get FDA fast track status for Jardiance to treat chronic kidney disease
Boehringer Ingelheim and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for the investigation of Jardiance (empagliflozin) to treat chronic kidney disease.
The designation will help investigate the efficacy of Jardiance to minimise the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Jardiance, a once-daily tablet, is used along with diet and exercise to reduce blood sugar in adults with type 2 diabetes, as well as minimise the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
Boehringer Ingelheim Pharmaceuticals clinical development and medical affairs vice president Dr Mohamed Eid said: “Chronic kidney disease can have a devastating impact on people’s lives. Not only does it cause damage to the kidneys that can eventually lead to the need for dialysis or transplant, but it could also increase the risk of cardiovascular death.”
The ongoing EMPA-KIDNEY clinical study is assessing the efficacy of Jardiance on the advancement of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes.
The EMPA-KIDNEY, a multinational randomised, double-blind and placebo-controlled clinical trial, plans to randomise around 6,000 participants to secure either Jardiance 10mg once daily or placebo, each on top of standard of care.
The study is based on significant exploratory data from the EMPA-REG OUTCOME trial, which showed that treatment with Jardiance minimised the risk of new-onset kidney disease by 39% in adults with type 2 diabetes.
In June 2019, the companies secured FDA fast track designation for the clinical investigation of Jardiance to minimise the risk of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure.
13 Marc 2020
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