Boehringer Ingelheim and Eli Lilly and Co. (NYSE: LLY) have received Fast Track designation for empagliflozin from the U.S. Food and Drug Administration. The designation will support studies to assess how the medication works to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
The Fast Track designation streamlines the development of new therapies that address "an unmet medical need for serious conditions in an effort to expedite the availability of new treatment options."
The EMPEROR-Reduced and EMPEROR-Preserved studies will evaluate the effect of empagliflozin on cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction.
"Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease," said Mohamed Eid, vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals Inc, in a news release. "The FDA Fast Track designation for empagliflozin is an important step forward in addressing this unmet need, and we look forward to working closely with the FDA as we explore the potential for empagliflozin to improve outcomes for adults with chronic heart failure."