FDA granted Fast Track designation to empagliflozin (Jardiance, Boehringer Ingelheim and Eli Lilly and Company) to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
The once-daily tablet Jardiance is a popular medication that treats type 2 diabetes.
“Heart failure contributes to 1 in 9 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, MD, MPH, vice president of clinical development & medical affairs for Boehringer Ingelheim, in a statement from the company. “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."
Already affecting 26 million people worldwide, including more than 6.5 million in the U.S., heart failure is expected to become even more prevalent, Boehringer Ingelheim said.
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This designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. The 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.
The two EMPEROR phase 3 studies include more than 8,500 people with chronic heart failure.