BOEHRINGER-INGELHEIM

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for empagliflozin as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. This follows results from the Phase III EMPEROR-Preserved trial which investigated the composite endpoint of cardiovascular death or hospitalization for heart failure in patients with HFpEF.¹

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“We are pleased that the FDA has recognized empagliflozin as a Breakthrough Therapy so soon after the publication of the EMPEROR-Preserved clinical trial results in HFpEF,” commented Ivan Blanarik, Head of Therapeutic Area CardioMetabolism & Respiratory, Boehringer Ingelheim. “Breakthrough Therapy Designation is testament to our commitment to the goal of improving outcomes for people affected by diseases across the cardio-renal-metabolic spectrum.”

HFpEF has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the previous absence of clinically proven therapies.^2,3 A leading cause of hospitalization in the U.S. and Europe, its prevalence is increasing and is estimated to affect approximately 30 million people worldwide – about half of all cases of heart failure.^4,5

Breakthrough designation is given to treatments of serious or life-threatening conditions where preliminary evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints compared to existing therapies.

The EMPEROR-Preserved Phase III trial results were presented during a hotline session of the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in The New England Journal of Medicine.

Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.^6,7,8 Additionally, empagliflozin is approved for the treatment of adults with heart failure with reduced ejection fraction (HFrEF), with or without diabetes, in the European Union and the U.S.^6,9 Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021.

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About the EMPEROR heart failure studies ^10,11
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies were two Phase III, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes:

• EMPEROR-Reduced [NCT03057977 ] investigated the safety and efficacy of empagliflozin in patients with chronic HFrEF.

• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 3,730
• Completion: 2020

• EMPEROR-Preserved [NCT03057951 ] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF.

• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 5,988
• Completion: 2021

About the EMPOWER program
The Boehringer Ingelheim and Lilly 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.¹² Through the EMPOWER program, the Alliance is working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine 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 enrolled worldwide in clinical studies, it is one of the broadest and most comprehensive clinical programs 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.¹³ To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.¹⁴ It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.^4,5 Heart failure is highly prevalent in people with diabetes; ¹⁵ however, more than half of all people with heart failure do not have diabetes.¹⁶

There are different types of heart failure. People with left-sided heart failure have either a reduced or a preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction.¹⁷ When the heart relaxes, the ventricle refills with blood.

• Heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out to the body.¹⁷
• Heart failure with reduced ejection fraction occurs when the left ventricle of the heart is not able to contract effectively, which means that the heart cannot pump with enough force, so less blood is pushed out to the body.¹⁷

People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.¹⁸ Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.¹⁹

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.^5,12

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, improvements in one system can lead to positive effects throughout the others.^20,21,22

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.^6,7,8

Please click on the following link for ‘Notes to Editors’ and ‘References’ http://www.boehringer-ingelheim.com/press-release/fda-hfpef-breakthrough-designation-emperor-preserved

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