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. 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.

“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 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. “