FDA Fast Tracks Empagliflozin to Improve Outcomes Following Heart Attack

September 18, 2020

Data showed that empagliflozin with standard of care was superior to placebo in reducing the risk of CV death or hospitalization.

Officials with the FDA have granted Fast Track designation to empagliflozin (Jardiance; Eli Lilly) to prevent hospitalization for heart failure (HF) and reduce the risk of mortality in patients who have previously had a heart attack, according to a press release.

Empagliflozin is a once-daily tablet currently indicated for use along with diet and exercise to lower blood sugar and reduce risk of cardiovascular (CV) death in adults with type 2 diabetes and known CV disease.

The EMPACT-MI phase 3 trial is investigating the effect of empagliflozin on all-cause mortality and hospitalization for heart failure in adults with and without type 2 diabetes who have had an acute myocardial infarction and no history of chronic heart failure.

“Ischemic heart disease (IHD) is the leading cause of death and disability in the US. Myocardial infarction, or heart attack, is the deadliest acute manifestation of IHD, and treatment options are urgently needed to help improve outcomes,” said Mohamed Eid, MD, MPH, MHA, vice president, clinical development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to working closely with the FDA as we explore the potential for Jardiance to improve survival and prevent hospitalization for heart failure for adults who have had a heart attack, through our EMPACT-MI trial.”

In the EMPEROR-Reduced phase 3 clinical study, data showed that, when added to standard of care, empagliflozin demonstrated superiority over placebo in reducing the risk of CV death or hospitalization for HF in adults with and without diabetes. The safety profile observed in the study was similar to the known safety profile of empagliflozin.

“The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack,” Jeff Emmick, MD, PhD, vice president, Product Development, Lilly, said in a statement. “We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure.”

According to Eli Lilly, results from the EMPACT-MI trial are expected in 2023.

Reference:

  1. US FDA grants Fast Track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack. News release. BioSpace; September 15, 2020. Accessed September 18, 2020. https://www.biospace.com/article/releases/us-fda-grants-fast-track-designation-to-jardiance-empagliflozin-to-improve-outcomes-following-a-heart-attack/.