Empagliflozin Receives FDA Fast Track Designation

The US Food and Drug Administration has granted Fast track designation to empagliflozin (Jardiance) for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure (HF).

The designation, which was announced by Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly Company, is for the ongoing empagliflozin outcome trial in patients with chronic heart failure (EMPEROR) program.

"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,” said Mohamed Eid, MD, MPH, MHA, Vice President of clinical development and medical affairs with Boehringer.

The EMPEROR program is made of 2 phase 3, randomized, double-blind trials known as EMPEROR-Preserved (NCT03057951) and EMPEROR-Reduced (NCT03057977). EMPEROR-Preserved will examine the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction. The primary endpoint will be the time to first event of adjudicated CV death or adjudicated hospitalization in an estimated population group of 5250 participants for up to 38 months. It expected to be completed in the fall of 2020.

EMPEROR-Reduced will examine the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction. The primary endpoint will be the time to first event of adjudicated HF or adjudicated HF hospitalization in an estimated population group of 3600 participants for up to 38 months. It is expected to be completed in the summer of 2020.

Empagliflozin is already received FDA indications as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

At ACC 2019 in New Orleans, investigators presented an analysis of the EMPA-Reg Outcome trial. The analysis found that empagliflozin was associated with a reduced risk of re-hospitalization, cardiovascular death, and all-cause death in type 2 diabetes mellitus patients with heart failure compared to placebo.

In an interview with MD Magazine® at ACC 2019, Gregg Fonarow, MD, director of the Ahmanson-UCLA Cardiomyopathy Center, praised the development of dimensional therapies for HF.

“People really tend to focus on MI and stroke risk, and not the substantial HF risk,” Fonarow said. “We’re really entering an era where a much greater focus is on a primary treatment for preventing HF. A lot of work needs to be done on more effective population health, and implementation to where our trials and guidelines can be applied routinely in practice.”