Ingelheim, Germany, 21.06.2021 – 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.2 The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021.
“Today’s approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and more time with their families.”
Marketing authorization is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization due to heart failure.3 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 hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.3
“Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “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.”
“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, M.D., Ph.D., Vice President, Product Development, Lilly. “We are committed to finding solutions for the millions of people who live with heart failure and important metabolic conditions around the world.”
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 attack4,5 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.6,7
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.
About the EMPEROR Heart Failure Studies8,9
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, with or 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] investigated 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: 5,988
- 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.10 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.4 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;11 however, approximately half of all people with heart failure do not have diabetes.12
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.10
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.13,14
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.15,16,17
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing some of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at
www.boehringer-ingelheim.com
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at
lilly.com and
lilly.com/newsroom.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about clinical trials to evaluate empagliflozin as a treatment for adults with heart failure and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
CONTACTS:
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Phone: +49 (6132) 77 172209
Greg Kueterman
Senior Director of Communications
Eli Lilly and Company
Phone: +1-317-432-5195
References
1 Cowie M, Anker S, Cleland J, et al. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014;1(2):110–45.
2 Committee for Medicinal Products for Human Use (CHMP). Jardiance summary of opinion (post authorisation). Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jardiance-ii-55_en.pdf. Accessed: June 2021.
3 Packer M, Anker SD, Butler J, et al. Cardiac and Renal Outcomes With Empagliflozin in Heart Failure With a Reduced Ejection Fraction. N Engl J Med. 2020;383:1413–24.
4 American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: June 2021.
5 Anderson JL and Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017;376:2053–64.
6 American Heart Association. Warning Signs of Heart Failure. Available at: https://www.heart.org/en/health-topics/heart-failure/warning-signs-of-heart-failure. Accessed June 2021.
7 Calvert MJ, Freemantle N, Cleland JGF. The impact of chronic heart failure on health‐related quality of life data acquired in the baseline phase of the CARE‐HF study. Eur J Heart Fail. 2005;7(2):243–51.
8 ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03057951. Accessed June 2021.
9 ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03057977. Accessed June 2021.
10 GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet. 2016; 388(10053):1459–544.
11 Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;128(16):e240–e327.
12 Suskin N, McKelvie RS, Burns RJ, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. Eur Heart J. 2000;21:1368–75.
13 Ronco C, McCullough P, Anker SD, et al. Cardio-renal syndromes: report from the consensus conference of the acute dialysis quality initiative. Eur Heart J. 2010;31(6):703–11.
14 Lazzeri C, Valente S, Tarquini R, et al. Cardiorenal syndrome caused by heart failure with preserved ejection fraction. Int J Nephrol. 2011;2011:634903.
15 Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: June 2021.
16 Jardiance® (empagliflozin) tablets. European Product Information; approved April 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf. Accessed June 2021.
17 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
