FDA Puts Empagliflozin on Fast Track for Reduced Post-MI All-cause Mortality

Fast-Track designation was awarded by the FDA to empagliflozin (Jardiance; Boehringer Ingelheim, Eli Lilly) for development of the sodium glucose contransporter-2 inhibitor to prevent hospitalization for heart failure and reduce the risk of mortality in patients who have had an acute myocardial infarction (MI) and have no history of chronic HF, regardless of presence of diabetes.

The news was announced on September 15, 2020 in a joint press release from the 2 companies.

Empagliflozin is being investigated in the ongoing randomized phase III EMPACT-MI trial that is being conducted, analyzed, and reported in partnership with the Duke Clinical Research Institute and funded by Boehringer Ingelheim and Lilly.

EMPACT-MI is part of the EMPOWER clinical program, a series of studies investigating the impact of empagliflozin in adults across a wide range of cardio-renal-metabolic conditions. The program is comprised of 8 clinical trials and 2 real-world studies and has enrolled more than 257 000 adults worldwide in the clinical studies.

“Ischemic heart disease is the leading cause of death and disability in the U.S. Myocardial infarction, or heart attack, is the deadliest acute manifestation of ischemic heart disease, and treatment options are urgently needed to help improve outcomes,” said Mohamed Eid, MD, MPH, MHA, vice president, clinical development and medical affairs, cardio-metabolism and respiratory medicine for Boehringer Ingelheim, in the press release. “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.”

Empagliflozin is currently approved to reduce hyperglycemia in adults with type 2 diabetes and for reducing risk of cardiovascular death in patients with type 2 diabetes and known cardiovascular disease.

In July, Boehringer Ingelheim and Eli Lilly announced that 10 mg empagliflozin to treat patients with HF with reduced ejection fraction, with and without diabetes, met its primary endpoint in the phase 3 EMPEROR-Reduced trial. That trial demonstrated that empagliflozin, added to standard of care, reduced the risk for a composite of CV death or HF hospitalization compared with placebo, regardless of the presence of type 2 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, M.D., Ph.D., vice president, Product Development, Lilly. “We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure. We look forward to learning the results of EMPACT-MI."

Results of this late-stage clinical trial are expected by 2023.