The FDA on June 26 granted Boehringer Ingelheim and Eli Lilly and Company’s drug empagliflozin Fast Track designation for the treatment of chronic heart failure, the companies announced.
Empagliflozin, marketed by U.S. pharmaceutical companies as Jardiance, was initially cleared as a once-daily tablet that, along with diet and exercise, helped lower blood sugar and reduce the risk of CV death in adults with type 2 diabetes. This is the first time empagliflozin has been indicated for use in heart failure patients, around half of whom die from the disease within five years of a diagnosis.
“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,” Mohamed Eid, MD, MPH, vice president of clinical development and medical affairs at Boehringer Ingelheim, said in a statement. “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.”
The FDA granted empagliflozin Fast Track designation explicitly for the purpose of the ongoing EMPEROR-Reduced and EMPEROR-Preserved studies, which will evaluate the effect of empagliflozin on CV death and hospitalization for heart failure in patients with chronic heart failure with reduced and preserved ejection fraction, respectively.
Combined, the two EMPEROR phase III studies include more than 8,500 patients with chronic heart failure.
“Boehringer Ingelheim and Lilly are committed to advancing treatments that address the public health challenges of cardiometabolic diseases, including chronic heart failure,” Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly, said in the statement. “We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting.”