Ridgefield-based Boehringer Ingelheim reported the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).
Jardiance was developed by Boehringer Ingelheim and Eli Lilly and Co. (NYSE: LLY). The sNDA is based on results from the landmark EMPA-KIDNEY phase III trial, in which Jardiance significantly reduced the risk of kidney disease progression or cardiovascular death in adults with CKD by 28% compared with placebo, both on top of standard of care.
“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” said Dr. Mohamed Eid, vice president for clinical development and medical affairs, cardio-renal-metabolism and respiratory medicine at Boehringer Ingelheim Pharmaceuticals Inc. “This application acceptance is an important step forward for the approximately 37 million people in the U.S. living with CKD.”
Jardiance is a one-daily tablet that was initially approved in 2014 for use along with diet and exercise to lower blood sugar in adults with type 2 diabetes; it is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
In March 2020, the FDA granted Fast Track designation to the clinical investigation of Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD. According to the FDA, Fast Track designation is designed to facilitate the development of drugs and expedite treatments that may address serious conditions and fill an unmet medical need. Jardiance is not indicated for the treatment of CKD.
