Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has received the green light from the U.S. Food and Drug Administration to fast track the evaluation of Jardiance for the treatment of chronic kidney disease.
Jardiance is currently marketed as a medication for type 2 diabetes, which was developed in collaboration with Boehringer Ingelheim.
The companies say the fast track designation illustrates the need for the medication for patients battling chronic kidney disease.
“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, M.D. vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals Inc. “There are still only limited treatment options, which is what motivates us to explore the potential role Jardiance may play in improving outcomes.”
Lilly and B-I say 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.
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 U.S.