9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction.
The U.S. FDA granted Breakthrough Therapy designation for Jardiance (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction, Boehringer Ingelheim and Eli Lilly and Company announced today.