Fast Track designation granted to chronic kidney disease treatment

The US Food and Drug Administration (FDA) has granted 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, Boehringer Ingelheim and Eli Lilly and Company have announced.

"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," said Mohamed Eid, MD, MPH, MHA, Vice President, Clinical Development & Medical Affairs at Boehringer Ingelheim Pharmaceuticals. "Chronic kidney disease is a common and deadly condition and there are still only limited treatment options, which is what motivates us to explore the potential role Jardiance may play in improving outcomes."

The ongoing EMPA-KIDNEY clinical study is evaluating the effect of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes. The study was initiated based on promising exploratory results from the EMPA-REG OUTCOME® trial, which found that treatment with Jardiance reduced the risk of new-onset and worsening kidney disease by 39 percent in adults with type 2 diabetes and established cardiovascular disease compared with placebo.

"We recognise the close link between the health of the heart, kidneys and metabolic system and we have committed to a broad clinical development programme assessing the cardiorenal metabolic benefits of Jardiance," added Jeff Emmick, MD, PhD, Vice President, Product Development at Lilly. "The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease."

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. 

In June 2019, the FDA granted Fast Track designation to the clinical investigation of Jardiance to reduce the risk of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure.

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