Boehringer Ingelheim and Eli Lilly’s Jardiance Granted FDA Breakthrough Therapy Designation for HFpEF

September 9, 2021—Boehringer Ingelheim and Eli Lilly and Company announced that the FDA granted Breakthrough Therapy designation for Jardiance (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF). The companies noted that the FDA Breakthrough Therapy designation is intended to expedite the development and review of therapies that are intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint.

According to the companies, the decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with HFpEF compared with placebo. The benefit was independent of ejection fraction or diabetes status.

Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 held virtually August 27-30, 2021. The study was simultaneously published by Stefan D. Anker, MD, et al online ahead of print in The New England Journal of Medicine.

The FDA previously granted Fast Track designation for the development of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials.

The EMPEROR-Reduced results formed the basis of the recent FDA approval for heart failure with reduced ejection fraction. Jardiance is not indicated for the treatment of HFpEF, advised the companies.