- The positive opinion is based on the EMPEROR-Reduced trial, which showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization for heart failure
- The results were observed in adults with heart failure with reduced ejection fraction (HFrEF), with or without diabetes
- Jardiance is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced.
“Heart failure is a progressive and debilitating condition affecting 60 million people worldwide. It is the leading cause of hospitalizations in Europe – not only impacting the quality of life considerably for those living with the condition but also putting significant pressure on healthcare systems,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “If Marketing Authorisation is granted by the European Commission, empagliflozin will provide an important additional treatment option for the millions of people in Europe already living with symptomatic chronic heart failure with reduced ejection fraction.”
The positive opinion is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization due to heart failure. The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.
“We are delighted with the CHMP’s decision to recommend empagliflozin as a treatment for people living with symptomatic chronic heart failure with reduced ejection fraction,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Today’s decision marks our entrance into a new chapter of heart failure management, enabling us to help address the challenges heart failure patients are facing in the EU and beyond.”
“Later this year, we expect trial results from our study in people with heart failure with preserved ejection fraction, another serious form of the condition. Our ongoing research of empagliflozin underscores the continued needs of people with serious metabolic conditions, and our collective commitment to finding solutions,” continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly.
In Europe, heart failure is the leading cause of hospitalization in people over the age of 65. 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. 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.