The U.S. Food and Drug Administration has granted Fast Track designation for the investigation of Jardiance for reducing the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
The drug, also known as empagliflozin, was developed by Boehringer Ingelheim and Eli Lilly and Co. An ongoing EMPA-KIDNEY clinical study is being conducted the Medical Research Council Population Health Research Unit at England’s University of Oxford in partnership with the Duke Clinical Research Institute at Duke University in North Carolina.
“Chronic kidney disease can have a devastating impact on people’s lives,” said Mohamed Eid, vice president of clinical development and medical affairs at Ridgefield-based Boehringer Ingelheim Pharmaceuticals Inc. “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. 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.”
Last June, the FDA granted Fast Track designation to the clinical investigation of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.