BRIEF—FDA grants Jardiance Breakthrough status in HFpEF

The US Food and Drug Administration has granted Breakthrough Therapy designation for Jardiance (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and partner Eli Lilly announced today.

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 heart failure with preserved ejection fraction 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 on August 27 and published in The New England Journal of Medicine.

HFpEF accounts for approximately half of the more than 6 million heart failure cases in the USA. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF.

This follows the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this is another important milestone supporting the potential of Jardiance as the first therapy clinically proven to improve outcomes across the full heart failure spectrum.”