CHMP Adopts Positive Opinion for Jardiance® (Empagliflozin) in Adults with Chronic Heart Failure and Reduced Ejection Fraction
Boehringer Ingelheim
Developer of Innovative Drugs and Therapies
Eli Lilly
Global Pharmaceutical R&D and Production Company
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
INGELHEIM, Germany, May 26, 2021 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Jardiance® (empagliflozin) to treat adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).[1]
Dr. Faiez Zannad, clinical investigator for the EMPEROR trials and Honorary Professor at the Faculty of Therapeutics, University of Lorraine, France, stated: “Heart failure is a progressive, debilitating disease that affects 60 million people worldwide.[2] Heart failure is a leading cause of hospitalization among patients in Europe, not only significantly impacting patients' quality of life but also placing a substantial burden on healthcare systems. If marketing authorization is granted by the European Commission, empagliflozin will provide an important new treatment option for millions of European patients with symptomatic chronic heart failure with reduced ejection fraction.”
This positive evaluation is based on the EMPEROR-Reduced clinical trial, which demonstrated that empagliflozin reduced the composite relative risk of cardiovascular death and hospitalization for heart failure by 25%.[3]Primary endpoint results were consistent across patient subgroups with and without type 2 diabetes. Analysis of key secondary endpoints demonstrated that empagliflozin reduced the relative risk of first and subsequent hospitalizations for heart failure by 30% and significantly slowed the decline in renal function.[4]
Dr. Waheed Jamal, Vice President and Head of Cardiovascular and Metabolic Medicines at Boehringer Ingelheim, stated: "We are pleased that the CHMP has recommended empagliflozin for the treatment of patients with symptomatic chronic heart failure with reduced ejection fraction. This decision marks a new chapter in heart failure management, enabling us to help heart failure patients in the European Union and other regions address the challenges they face."
Dr. Jeff Emmick, Vice President of Product Development at Eli Lilly and Company, said: "Later this year, we expect to receive clinical trial results for Jardiance in patients with heart failure with preserved ejection fraction, another severe form of heart failure. The clinical studies we are conducting with empagliflozin underscore our focus on the ongoing needs of patients with serious metabolic diseases, as well as our shared commitment to finding solutions."
In Europe, heart failure is the leading cause of hospitalization among patients aged 65 years and older. When heart failure occurs, the heart is unable to pump sufficient blood to the rest of the body. It is the most common and severe complication of myocardial infarction.[4],[5]. Patients with heart failure frequently experience shortness of breath and fatigue, significantly impairing their quality of life. [6],[7]
The EMPEROR trial is part of the EMPOWER clinical research program, one of the broadest and most comprehensive clinical research programs among all SGLT2 inhibitors, designed to explore the impact of empagliflozin on the lives of patients with various cardio-renal-metabolic diseases.
About the EMPEROR Heart Failure Study[8],[9]
The EMPEROR (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure) chronic heart failure studies comprise two Phase III, randomized, double-blind trials evaluating adult patients with chronic heart failure with reduced ejection fraction and preserved ejection fraction (including patients with and without diabetes mellitus), on a background of standard of care, to investigate the efficacy and safety of once-daily empagliflozin compared with placebo:
AboutEMPOWERItem
The Alliance developed the EMPOWER program to investigate the impact of empagliflozin on major clinical cardiovascular and renal outcomes across a range of cardio-renal-metabolic diseases. Cardio-renal-metabolic diseases are a leading cause of death worldwide, accounting for up to 20 million deaths annually.[10]Through the EMPOWER program, Boehringer Ingelheim and Eli Lilly are working to increase awareness of these interconnected systems and develop therapies that deliver comprehensive, multi-organ benefits. Comprising 8 studies and 2 real-world studies, EMPOWER reinforces the alliance's long-term commitment to improving clinical outcomes for patients with cardiorenal-metabolic diseases. With more than 400,000 adult patients enrolled globally across its clinical research, EMPOWER is the most extensive and comprehensive clinical research program to date for an SGLT2 inhibitor.
About Heart Failure
Heart failure is a progressive, debilitating, and potentially fatal condition that occurs when the heart is unable to maintain adequate circulation to meet the body’s demand for oxygenated blood, or when the need for increased blood volume leads to fluid accumulation (congestion) in the lungs and peripheral tissues. Heart failure is a widespread disease affecting 60 million people globally, and its incidence is expected to increase with the aging population. Heart failure is highly prevalent among patients with diabetes.[11], but approximately half of patients with heart failure do not have diabetes.[3],[12]
# About the Heart-Kidney-Metabolic Diseases
Boehringer Ingelheim and Eli Lilly aim to transform the treatment of patients with cardiorenal-metabolic diseases, a group of interrelated conditions affecting over 1 billion people worldwide and representing a leading cause of death.[12]
The cardiovascular, renal, and metabolic systems are interconnected and share numerous common risk factors and pathophysiological pathways across the disease spectrum. Dysfunction in one system may accelerate disease onset or progression in others, leading to the development of interrelated conditions such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn increases the risk of cardiovascular mortality. Conversely, improving the health of one system can confer beneficial effects across the others.[13],[14]
Through our research and therapies, we aim to support individuals' health, restore balance within the interconnected cardiorenal-metabolic system, and reduce their risk of serious complications. As part of our commitment to patients whose health is compromised by cardiorenal-metabolic diseases, we will continue to explore multidisciplinary treatment approaches and focus our resources on addressing treatment gaps.
About Empagliflozin
Empagliflozin (brand name Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medication to include data on reducing the risk of cardiovascular death in the prescribing information across numerous countries.[15],[16],[17]
About Boehringer Ingelheim and Eli Lilly
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced a collaboration agreement covering multiple products across several classes of antidiabetic medications. Depending on the market, the two companies will choose to either co-promote or independently promote the drugs each contributes to the partnership. This collaboration integrates the strengths of two global leading pharmaceutical companies focused on patient needs. Through this joint effort, both companies are committed to supporting patients with diabetes and addressing their unmet medical needs. Clinical trials evaluating the effects of empagliflozin in patients with heart failure or chronic kidney disease have been initiated.
About Boehringer Ingelheim
Boehringer Ingelheim is dedicated to researching breakthrough therapies to improve human and animal health. As a research-driven global leader in biopharmaceuticals, the company delivers value through innovation in areas of high unmet medical need. Since its founding in 1885, Boehringer Ingelheim has remained an independent family-owned company, and this will not change in the long term. Across its three business areas—Human Pharmaceuticals, Animal Health, and Biopharmaceutical Contract Manufacturing—approximately 52,000 employees worldwide serve more than 130 markets. For more information, please visit:www.boehringer-ingelheim.com
About Eli Lilly and Company
As a global leader in the healthcare industry, Eli Lilly is committed to serving patients through innovation and nurturing life with care. For over 140 years since its founding, Eli Lilly has consistently upheld the philosophy of providing patients with the highest-quality medicines using the latest technologies, a commitment that remains true to the promise made by the company’s founder, Colonel Eli Lilly. Today, Eli Lilly remains steadfast in this mission, which continues to guide all its operations. Eli Lilly employees worldwide are not only dedicated to researching and developing life-saving medicines and actively helping patients better understand and manage their diseases, but also wholeheartedly giving back to society through charitable and public welfare initiatives. For more information about Eli Lilly, please visithttp://www.lilly.comandhttps://newsroom.lilly.com/social-channels.
References
[1] 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: May 2021.
[2] GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–1858.
[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;10.1056/NEJMoa2022190.
[4] American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: April 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 April 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 April 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 April 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: April 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 April 2021.
[17] Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.