CHMP gives positive opinion on Jardiance® (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction

INGELHEIM, Germany – (BUSINESS WIRE) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued 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 disease that affects 60 million people worldwide.2 It is the leading cause of hospitalization in Europe. It not only seriously affects the quality of life of those affected, but also puts considerable pressure on health systems.” said Dr. med. Faiez Zannad, Clinical Examiner of the EMPEROR Program and Professor Emeritus of Therapeutics at the University of Lorraine, France. “If the European Commission grants marketing authorization, empagliflozin will represent an important additional treatment option for the millions of people in Europe who already have symptomatic chronic heart failure with reduced ejection fraction.”

The positive opinion is based on the results of the EMPEROR-reduced study, in which empagliflozin showed a significant reduction in the combined relative risk of cardiovascular death or hospitalization due to heart failure by 25 percent.3 The results from the primary endpoint agreed in subgroups with and without type- 2 diabetes. Key secondary endpoint analyzes from the study showed that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed the decline in renal function

“We are pleased with the CHMP’s decision to recommend empagliflozin for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction,” said Dr. Waheed Jamal, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Today’s decision marks our entry into a new chapter in heart failure management that will enable us to address the challenges facing heart failure patients in the EU and beyond.”

“Later this year, we expect study results from our study in people with heart failure with conserved ejection fraction, another serious form of the disease. Our ongoing research on empagliflozin underscores the ongoing needs of people with severe metabolic disorders and our shared commitment to finding solutions, ”continued Dr. Jeff Emmick, Vice President, Product Development at Lilly, continues.

In Europe, heart failure is the leading cause of hospitalization for people over 65.4 years of age. Heart failure is a very common and serious complication of a heart attack5,6 and occurs when the heart cannot pump enough blood to the rest of the body. People with heart failure often experience shortness of breath and fatigue, which can seriously affect their quality of life.7,8

The EMPEROR-reduced study is part of the EMPOWER clinical program, the broadest and most comprehensive of all SGLT2 inhibitors, which examines the effects of empagliflozin on human lives across the spectrum of cardio-renal metabolic diseases.

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About the EMPEROR Heart Failure Studies9,10

The EMPEROR studies (EMPagliflozin outcomE tRial in patients with chronic heart failure) are two randomized, double-blind phase III studies in which empagliflozin was compared to placebo in adults with heart failure with conserved or reduced ejection fraction both with and examined once a day without diabetes who receive the 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 judged cardiovascular death or convicted hospitalization for heart failure

• Number of patients: 3,730

• Completion: 2020

• Link to the summary

• Kaiser-preserved [NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with conserved ejection fraction (HFpEF).

• Primary endpoint: time to first event of judged cardiovascular death or convicted hospitalization for heart failure

• Number of patients: approx. 5,989

• Completion: 2021

About the EMPOWER program

The Alliance developed the EMPOWER program to study the effects of empagliflozin on key clinical cardiovascular and renal outcomes in a spectrum of cardio-renal metabolic diseases. Cardio-kidney metabolic diseases are the leading cause of death worldwide, causing up to 20 million deaths annually.11 As part of the EMPOWER program, Boehringer Ingelheim and Lilly are working to expand knowledge of these interconnected systems and to create care that is integrated organ offers many advantages. EMPOWER consists of eight clinical studies and two real-world evidence studies and reaffirms the alliance’s long-term commitment to improve outcomes for people with cardiovascular disease. With more than 400,000 adults investigated in clinical trials worldwide, it is the most comprehensive and comprehensive clinical program to date for an SGLT2 inhibitor.

About heart failure

Heart failure is a progressive, debilitating, and potentially fatal disease that occurs when the heart cannot provide sufficient blood flow to meet the body’s needs for oxygenated blood, or when it requires increased blood volume that leads to fluid retention (congestion) in the body the lungs and peripheral tissues. 6 It is a widespread disease affecting over 60 million people worldwide and is expected to increase as the population ages. Heart failure is common 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 committed to transforming the way we care for people with cardiovascular disease, a group of interrelated diseases that affect more than a billion people worldwide and are one of the leading causes of death

The cardiovascular, renal, and metabolic systems are interconnected and share many of the same risk factors and pathological pathways along the disease continuum. A dysfunction in one system can accelerate the occurrence of other diseases and lead to the progression of related diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn increases the risk of cardiovascular death. Conversely, improving the health of one system can have positive effects on all others.14,15

Our goal is through our research and treatments to support people’s health, restore the balance between the interconnected cardio-renal metabolic systems, and reduce the risk of serious complications. As part of our commitment to those whose health is at risk from cardio-renal metabolic disorders, we will continue to take a multidisciplinary approach to care and focus our resources on addressing treatment gaps.

About empagliflozin

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

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