Boehringer Ingelheim has received fast track designation from the U.S. Food and Drug Administration (FDA) for the development of Jardiance (empagliflozin) to prevent hospitalization for heart failure and reduce the risk of mortality in patients who experienced a heart attack.
Jardiance is a drug used for lowering blood sugar in adults with type 2 diabetes and reducing the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. The drug is undergoing a randomized clinical phase three trial in partnership with the Duke Clinical Research Institute with funding by Boehringer Ingelheim and Eli Lilly & Co. The trial results are expected by 2023.
In March, the Danbury-based company received FDA 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.
“Ischemic heart disease (IHD) is the leading cause of death and disability in the U.S. Myocardial infarction, or heart attack, is the deadliest acute manifestation of IHD, and treatment options are urgently needed to help improve outcomes,” said Dr. Mohamed Eid, vice president of clinical development and medical affairs for cardio-metabolism and respiratory medicine at Boehringer Ingelheim Pharmaceuticals Inc.
“We look forward to working closely with the FDA as we explore the potential for Jardiance to improve survival and prevent hospitalization for heart failure for adults who have had a heart attack.”