Jardiance becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction. Boehringer + Eli Lilly

The landmark approval makes Jardiance the first and only approved treatment for all adults with symptomatic chronic heart failure, which includes patients across the full spectrum of LVEF, including both heart failure with reduced and preserved ejection fraction (HFrEF and HFpEF).

Heart failure affects more than 15 million people in Europe and causes almost 2 million hospital admissions yearly. Approximately half of these patients have HFpEF, which has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the absence of treatment options until now.

The approval is based on results from the breakthrough EMPEROR-Preserved Phase III trial, which investigated the effect of empagliflozin 10 mg compared with placebo once daily, both added to the standard of care, in 5,988 adults with heart failure with LVEF over 40%. In the trial, empagliflozin demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. Established benefit was regardless of ejection fraction or diabetes status. Empagliflozin was previously approved for the treatment of adults with symptomatic chronic HFrEF.