CHMP Adopts Positive Opinion for Jardiance (Empagliflozin) to Treat Adults with Heart Failure with Preserved Ejection Fraction Based on Unprecedented Clinical Benefit
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, February 10, 2022 /PRNewswire/ -- Boehringer Ingelheim andEli Lilly and CompanyIt was recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted Jardiance®(Empagliflozin) is strongly recommended for the treatment of adult patients with symptomatic chronic heart failure.[1]Empagliflozin was previously approved for the treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF).[3]Once approved, this positive opinion will expand the indication of Jardiance to include adult patients with chronic heart failure across all left ventricular ejection fraction (LVEF) categories, including those with heart failure with preserved ejection fraction (HFpEF).
"We now have, for the first time, a treatment that can improve clinical outcomes for all types of heart failure patients."--Regardless of its ejection fraction, "EMPEROR-Preserved principal investigator, Charitè Berlin, Germanye"Heart failure disease expert Professor Stefan Anker said, 'Half of the heart failure patients are those with preserved left ventricular ejection fraction. Due to the lack of clinically proven beneficial therapies, they suffer from disease symptoms and have poor prognoses. The positive opinion given by the EMA on Jardiance is an important step in redefining the clinical treatment of heart failure, providing a new therapeutic option for millions of HFpEF patients in Europe.'"
Positive opinions are based on the landmark EMPEROR-Preserved Phase III clinical trial results, which were conducted in 5,988 adult heart failure patients with LVEF greater than 40%, exploring the efficacy of once-daily 10mg empagliflozin added to standard-of-care compared with placebo.[4]The trial results showed that empagliflozin reduced the relative risk of the composite primary endpoint of cardiovascular death or hospitalization for heart failure by 21% (absolute risk reduction 3.3%, 0.79 HR, 0.69-0.90 95% CI), a finding that was striking. The benefits were independent of ejection fraction or diabetes status.[5]
"We are delighted that the CHMP has decided to recommend empagliflozin as a treatment for adult patients with chronic heart failure," said Waheed Jamal, MD, Vice President and Head of Cardio-Metabolic Medicine at Boehringer Ingelheim. "The heart, kidneys, and metabolic systems are interconnected, and our understanding of this interconnection has allowed us to expand from diabetes to heart failure, following the science to provide solutions for some of medicine's greatest challenges. We are proud to bring new hope to patients with unmet needs, as demonstrated by the unprecedented clinical benefits shown in the EMPEROR-Preserved trial."
"Jeff Emmick, M.D., Ph.D., Vice President of Product Development at Eli Lilly and Company, stated: 'This positive opinion highlights a significant unmet need in cardiovascular medicine, confirming the therapeutic potential of empagliflozin for chronic heart failure across all ejection fraction types. We are committed to ongoing research in areas with unmet needs and look forward to the results of the EMPA-KIDNEY clinical trial, exploring the therapeutic potential of empagliflozin in chronic kidney disease.'"
The EMPEROR-Preserved trial is part of the EMPOWER clinical research program, which is the broadest and most comprehensive clinical research program among all SGLT2 inhibitors, aiming to explore the impact of empagliflozin on the lives of patients with various cardio-renal-metabolic diseases.
About the EMPEROR Heart Failure Study[5,6]
EMPEROR (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure) chronic heart failure research includes two Phase III, randomized, double-blind trials targeting adult patients with chronic heart failure with preserved ejection fraction and reduced ejection fraction (both including patients with or without diabetes). On the basis of standard treatment, the efficacy and safety of once-daily empagliflozin compared to placebo were investigated.
EMPEROR-Preserved [NCT03057951]: To evaluate the safety and efficacy of empagliflozin in treating patients with chronic heart failure with preserved ejection fraction (HFpEF).
AboutEMPOWERProject
The Alliance developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes across a range of cardio-renal-metabolic diseases. Cardiorenal metabolic diseases are a leading cause of death globally, resulting in up to 20 million deaths annually.[7]Through the EMPOWER program, Boehringer Ingelheim and Eli Lilly are working to increase awareness of these interconnected systems and develop treatments that provide integrated, multi-organ benefits. EMPOWER consists of 8 studies and 2 real-world studies, reinforcing the alliance's long-term commitment to improving clinical outcomes for patients with cardio-renal-metabolic diseases through the EMPEROR program. With over 400,000 adult patients enrolled globally in clinical studies, EMPOWER is the most extensive and comprehensive clinical research program conducted to date for SGLT2 inhibitors.
About Heart Failure
Heart failure is a progressive, debilitating, and potentially fatal condition that occurs when the heart is unable to supply sufficient circulation to meet the body's demand for oxygenated blood or when increased blood volume is required, leading to fluid accumulation (congestion) in the lungs and peripheral tissues. [8,9]Heart failure is a widespread condition affecting 60 million people globally, with its incidence expected to rise as the population ages.[3,10]Heart failure is very common in patients with diabetes, but about half of the patients with heart failure do not have diabetes.[11,12]
About the Heart-Kidney-Metabolic Diseases
Boehringer Ingelheim and Eli Lilly hope to change the treatment approach for patients with cardio-renal-metabolic diseases, a group of interrelated conditions that affect more than 1 billion people worldwide and are a leading cause of death.。[11,13]
The cardiovascular, renal, and metabolic systems are interrelated, sharing many of the same risk factors and pathological pathways in the disease spectrum. Dysfunction in one system may accelerate the onset of diseases in others, leading to the development of interconnected 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 positively impact the others.。[14,15]
Through our research and treatment, our goal is to support people's health, restore the balance between the interconnected heart-kidney-metabolic systems, and reduce their risk of developing serious complications. As part of our commitment to patients whose health is threatened by cardiorenal metabolic diseases, we will continue to explore multidisciplinary treatment options and focus our resources on addressing unmet treatment needs.
About Empagliflozin
Empagliflozin (trade name: Jardiance) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and was the first type 2 diabetes drug to include data on reducing the risk of cardiovascular death in the prescribing information across many countries.。[17,18]
About Boehringer Ingelheim and Eli Lilly
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced a collaboration agreement covering multiple types of antidiabetic drugs. Based on different markets, the two companies will choose to co-promote or individually promote the drugs provided under this partnership. This collaboration combines the strengths of two global leading pharmaceutical companies dedicated to patient needs. By working together, both companies are committed to helping diabetes patients and exploring solutions for unmet medical needs. Clinical trials assessing the impact of empagliflozin on patients with heart failure or chronic kidney disease have been initiated.
About Boehringer Ingelheim
Boehringer Ingelheim is committed to researching breakthrough therapies aimed at improving the health of humans and animals. As a globally leading biopharmaceutical company driven by research and development, the company demonstrates its value through innovation in areas of high unmet medical need. Since its founding in 1885, Boehringer Ingelheim has remained an independent, family-owned enterprise—a fact that will not change in the long term. Across its three core business areas—human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing—the company serves over 130 regions with approximately 52,000 employees worldwide. For more information, please visit:www.boehringer-ingelheim.com
About Eli Lilly and Company
As a global leader in the healthcare industry, Eli Lilly and Company is committed to rewarding patients with innovation and cherishing lives with care. For over 140 years since its founding, Eli Lilly has adhered to the principle of providing patients with the highest quality medicines using the latest technology—a commitment that remains true to the promise made by the company’s founder, Colonel Eli Lilly. Today, Eli Lilly continues to pursue this mission with dedication, shaping all aspects of its work accordingly. Around the world, employees of Eli Lilly not only focus on developing life-saving medicines and actively helping patients better understand and manage their conditions, but also wholeheartedly give back to society through charitable and public welfare activities. For more information about Eli Lilly and Company, please visitlilly.comAndlilly.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.
References
[1] Andersen MJ, Borlaug BA. Heart failure with preserved ejection fraction: current understandings and challenges. Curr
Cardiol Rep. 2014 Jul;16(7):501.
[2] Lippi G, Sanchis-Gomar F. Global epidemiology and future trends of heart failure. AMJ. 2020;5:15
[3] Committee for Medicinal Products for Human Use (CHMP). Jardiance European Public Assessment Report (EPAR)
summary. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/jardiance. Accessed: January 2022.
[4] Anker S, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med.
2021;10.1056/NEJMoa2107038.
[5] 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: January 2022.
[6] 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: January 2022.
[7] 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
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[8] American Heart Association. What is Heart Failure? Available at:
https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: January 2022.
[9] American Heart Association. Types of Heart Failure. Available at:
https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/types-of-heart-failure. Accessed: January 2022.
[10] 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):1789–858.
[11] Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019;124(1):121–41.
[12] Dunlay SM, Givertz MM, Aguilar D, et al. Type 2 Diabetes Mellitus and Heart Failure: A Scientific Statement From
the American Heart Association and the Heart Failure Society of America. Circulation. 2019;140:e294–e324.
[13] Thomas M, Cooper M, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney
disease. Nat Rev Nephrol. 2015;12:73–81.
[14] García-Donaire JA, Ruilope LM. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol.
2011;2011:975782.
[15] Leon BM, Maddox TM. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment
recommendations and future research. World J Diabetes. 2015;6(13):1246–58.
[17] 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: January 2022.
[18] Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at:
http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: January 2022.