The Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) to prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had an acute myocardial infarction (MI).
The effect of empagliflozin on all-cause mortality and hospitalization for heart failure will be evaluated in the in phase 3 EMPACT-MI study. The trial is being conducted in partnership with the Duke Clinical Research Institute and is expected to enroll over 3300 patients who have had an acute MI and no history of chronic heart failure.
EMPACT-MI is part of the EMPOWER program, which is comprised of studies aimed to investigate the effects of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Recent results from the EMPEROR-Reduced trial showed that empagliflozin reduced the risk for heart failure hospitalization and slowed kidney function decline in patients with heart failure with markedly reduced ejection fraction, including those with concomitant diabetes.
“The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly. “We look forward to learning the results of EMPACT-MI, which are anticipated in 2023.”
Jardiance, a sodium-glucose cotransporter (SGLT2) inhibitor, is already approved to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes and established CV disease. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack. https://www.prnewswire.com/news-releases/us-fda-grants-fast-track-designation-to-jardiance-empagliflozin-to-improve-outcomes-following-a-heart-attack-301130575.html. Accessed September 15, 2020.
This article originally appeared on MPR