The European Commission ( EC ) has granted marketing authorization for Jardiance ( Empagliflozin ), an oral, once-daily, highly selective sodium-glucose cotransporter 2 ( SGLT2 ), as a treatment for adults with symptomatic chronic heart failure.
Jardiance is 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.
The approval is based on results from the breakthrough EMPEROR-Preserved phase III trial, which has 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 has demonstrated a 21% relative risk reduction ( 3.3% absolute risk reduction, 0.79 HR ( hazard ratio ), 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.
The EMPEROR ( EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure ) chronic heart failure trials were two phase III, randomized, double-blind trials that investigated once-daily Empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes:
a) EMPEROR-Reduced has investigated the safety and efficacy of Empagliflozin in patients with chronic HFrEF. Primary endpoint was time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure; number of patients: 3,730.
b) EMPEROR-Preserved has investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF. Primary endpoint was time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure; number of patients: 5,988.
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood, or to do so, requires increased blood volume leading to fluid congestion in the lungs and peripheral tissues. ( Xagena )
Source: Boehringer Ingelheim & Eli Lilly, 2022