The European Commission has granted marketing authorization for Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure), Boehringer Ingelheim and Eli Lilly and Company have announced. The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021.
Marketing authorisation is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 per cent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalisation due to heart failure.The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes.
Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalisation for heart failure by 30 per cent and significantly slowed kidney function decline.
“Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes. We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status.
We look forward to collaborating with regulators in Europe and beyond to ensure access to this trusted therapy,” said Waheed Jamal, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“As we enter this new chapter of heart failure management, we can now look ahead to results from the EMPEROR-Preserved trial, expected this year. This trial will explore empagliflozin in heart failure with preserved ejection fraction, in adults with or without diabetes,” continued Jeff Emmick, Vice President, Product Development, Lilly.
Heart failure is often associated with other diseases of the cardio-renal-metabolic systems such as type 2 diabetes and kidney disease. Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others. Heart failure is a very common and severe complication of a heart attack and occurs when the heart cannot pump sufficient blood to the rest of the body.
There are two forms of the condition; heart failure with reduced ejection fraction means the heart cannot contract normally, while preserved ejection fraction means the heart cannot properly fill with blood. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.
The EMPEROR-Reduced 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.