FDA fast tracks empagliflozin for reduced all-cause mortality, HF hospitalization risk
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The FDA has fast tracked the development of empagliflozin to prevent hospitalization for heart failure and reduce risk for all-cause mortality in adults with and without diabetes with a previous myocardial infarction.
The ongoing EMPACT-MI study is investigating the effect of empagliflozin (Jardiance, Boehringer Ingelheim and Eli Lilly), an SGLT2 inhibitor, on all-cause mortality and hospitalization for heart failure (HF) in adults with and without type 2 diabetes who have had an acute MI and no history of chronic HF. The randomized, phase 3 trial is being conducted, analyzed and reported in partnership with the Duke Clinical Research Institute, funded by Boehringer Ingelheim and Eli Lilly.
EMPACT-MI is part of the EMPOWER clinical program, a series of studies exploring the impact of empagliflozin in adults across the spectrum of cardio-renal-metabolic conditions.
“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,” Mohamed Eid, MD, MPH, MHA, vice president, clinical development and medical affairs, cardio-metabolism and respiratory medicine for Boehringer Ingelheim, said in the 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 a once-daily tablet used along with diet and exercise to lower blood glucose in adults with type 2 diabetes and to reduce the risk for cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
As Healio previously reported, Boehringer Ingelheim and Eli Lilly announced in July 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, according to a press release from the companies.
“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 of product development at Lilly, said in the release. “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, which are anticipated in 2023.”
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