Empagliflozin Earns FDA Fast Track Designation for Chronic Heart Failure
The drug is earned the designation for reducing the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
Fast Track designation for empagliflozin (Jardiance, Boehringer Ingelheim and Eli Lilly) has been granted by the FDA for a new indication. According to Boehringer Ingelheim, the drug is earned the designation for reducing the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
Empagliflozin is a once-daily tablet with previous FDA approvals. It is used with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
The new Fast Track designation is for the ongoing EMPEROR program, which is comprised of the EMPEROR-Reduced and EMPEROR-Preserved studies. These 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, respectively, according to Boehringer Ingelheim.
“Heart failure contributes to 1 in 9 deaths and is a leading cause of hospitalization in the US, yet there are limited treatment options for people living with this debilitating disease,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim, in a prepared 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.”
About half of people who develop heart failure die within 5 years, according to Boehringer Ingelheim. Heart failure also leads to a substantial reduction in quality of life and a high symptom burden, in part due to limitation of physical activity and difficulty carrying out typical everyday activities. Approximately 26 million people worldwide are affected, including more than 6.5 million people in the United States, and heart failure is expected to become even more prevalent.
The 2 EMPEROR phase III studies include more than 8500 people with chronic heart failure and are designed to assess the effect of treatment with empagliflozin on cardiovascular death and
hospitalization for chronic heart failure as primary endpoints.
“Boehringer Ingelheim and Lilly are committed to advancing treatments that address the public health challenges of cardiometabolic diseases, including chronic heart failure,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly, in a prepared statement. “We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting.”
According to Boehringer Ingelheim, the most common adverse effects of empagliflozin are yeast infections in females and urinary tract infections. Other adverse effects caused by empagliflozin include dehydration, yeast infection of the penis, ketoacidosis, kidney problems, low blood sugar, necrotizing fasciitis, increased cholesterol, and allergic reactions.
This drug is not indicated for people with type 1 diabetes or for people with diabetic ketoacidosis. Individuals with severe kidney problems, including those on dialysis, should not take empagliflozin.
U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure [news release]. Ridgefield, CT and Indianapolis, IN; June 26, 2019: Boehringer Ingelheim. https://www.boehringer-ingelheim.us/press-release/us-fda-grants-fast-track-designation-empagliflozin-treatment-chronic-heart-failure? Accessed June 26, 2019.