INGELHEIM, GERMANY-- March 07, 2022 -- The European Commission (EC) has granted marketing authorization for Jardiance® (empagliflozin) as a treatment for adults with symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company have announced.[1] 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.[2] Approximately half of these patients have HFpEF,[3] 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.[4,5]
“It’s estimated that over 60 million people worldwide are living with heart failure. This complex medical condition very often has a devastating impact on quality of life: physically, emotionally and even financially for those who can no longer work,” said Neil Johnson, Executive Director of the Global Heart Hub. “New treatments for a heretofore underserved population of patients which can improve outcomes and reduce hospital admissions is just great news for patients. The impact of new and emerging treatments on quality of life, from a patient and carer perspective, cannot be overstated because they provide hope and comfort in the knowledge that heart failure can be treated. This in turn has an enormously positive impact on overall mental health and wellbeing by decreasing anxiety, stress and worry.”
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%.[6] 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.[6] Empagliflozin was previously approved for the treatment of adults with symptomatic chronic HFrEF.
“The European approval will redefine the standard of care for millions of people in the EU living with heart failure,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are writing history as the first and only approved treatment to show significant clinical benefits for adults with heart failure across the range of left ventricular ejection fraction. This approval reinforces empagliflozin‘s potential to transform the lives of adults with chronic heart failure and builds on Boehringer Ingelheim and Lilly’s legacy of leadership in this space.”
“We are delighted with the EC decision to approve empagliflozin as the first and only treatment for adults with symptomatic chronic heart failure, following our recent U.S. FDA approval,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “This is an essential step forward in our efforts to advance treatment options for people with a range of cardio-renal-metabolic conditions. We continue to explore empagliflozin’s ability to improve outcomes across these conditions and look forward to the upcoming results from the EMPA-KIDNEY trial, which explores the potential of empagliflozin in treating chronic kidney disease.”
The EMPEROR-Preserved trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
