- 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

INGELHEIM, Germany--(BUSINESS WIRE)--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.1

“Heart failure is a progressive and debilitating condition affecting 60 million people worldwide.2 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.3 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.4

“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 65.4 Heart failure is a very common and severe complication of a heart attack5,6 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.7,8

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.

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About the EMPEROR Heart Failure Studies9,10

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care:

• EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 3,730
• Completion: 2020
• Link to lay summary
• EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: approx. 5,989
• Completion: 2021

About the EMPOWER program

The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.11 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 400,000 adults studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.

About Heart Failure

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 accumulation (congestion) in the lungs and peripheral tissues.6 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.3,13

About Cardio-Renal-Metabolic Conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.12

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.14,15

Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.16,17,18

Please click on the following link for ‘Notes to Editors’ and ‘References’ http://www.boehringer-ingelheim.com/press-release/emperor-reduced-chmp-positive-opinion