Jardiance® (Empagliflozin) Receives EU Approval as First and Only Therapy for Symptomatic Chronic Heart Failure in Adults Regardless of Ejection Fraction
Boehringer Ingelheim
Developer of Innovative Drugs and Therapies
Eli Lilly
Global Pharmaceutical R&D and Production Company
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Abstract:The first and currently only approved therapy for the treatment of symptomatic chronic heart failure in adult patients (regardless of the patient's ejection fraction)
Ingelheim, Germany, March 7, 2022 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company announced that the European Commission (EC) has granted Jardiance®（Empagliflozin) has been granted marketing authorization for the treatment of adult patients with symptomatic chronic heart failure. Today's landmark approval allows Jardiance®Becoming the first and currently only therapy approved in Europe for the treatment of all symptomatic chronic heart failure adult patients, including patients with all types of LVEF, i.e., heart failure with reduced and preserved ejection fraction (HFrEF and HFpEF) patients.
Heart failure affects more than 15 million people in Europe and results in nearly 2 million hospital admissions each year.[1]Approximately half of these patients have HFpEF,[2]Based on its prevalence, poor prognosis, and the lack of treatment options until now, HFpEF has been described as a significant unmet need in the field of cardiovascular medicine.[3],[4]
"An estimated 60 million people worldwide are living with heart failure. This complex condition often has a devastating impact on patients' quality of life, particularly for those unable to work, affecting them physically, emotionally, and even financially," said Neil Johnson, Executive Director of the Global Heart Hub. "New therapies that can improve outcomes and reduce hospitalization risks are welcome news for patients with unmet needs. The impact of emerging therapies on patients' quality of life cannot be overstated, as they bring hope and relief to the field of heart failure treatment. By reducing anxiety, stress, and worry, these therapies also have a significant positive effect on patients' overall mental health and well-being."
The approval was based on the groundbreaking EMPEROR-Preserved®Results from the Phase III clinical trial, which was conducted in 5,988 adult heart failure patients with LVEF over 40%, explored the efficacy of once-daily addition of 10mg empagliflozin compared to placebo on top of standard treatment.[6]The trial 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%, HR: 0.79, 95% CI: 0.69-0.90). The known benefits are independent of ejection fraction or diabetes status.[5]Empagliflozin has previously been approved in Europe for the treatment of adult patients with symptomatic chronic HFrEF.
"Today's approval of this indication in Europe will redefine the standard treatment for millions of heart failure patients in the EU," said Dr. Waheed Jamal, Vice President of Boehringer Ingelheim and Head of Cardio-Metabolic Medicine. "We are once again making history by becoming the first and currently the only therapy approved to demonstrate significant clinical benefits in adult heart failure patients, regardless of their left ventricular ejection fraction. This approval solidifies the treatment potential of empagliflozin to transform the lives of adults with chronic heart failure and builds on the leadership of Boehringer Ingelheim and Eli Lilly in this field."
“Following our recent FDA approval, we are pleased with the EC’s decision to approve empagliflozin as the first and currently only treatment for adults with symptomatic chronic heart failure,” said Jeff Emmick, M.D., Ph.D., vice president of product development at Eli Lilly and Company. “This is an important step forward in our efforts to provide treatment options for people with a range of cardio-renal-metabolic conditions. We will continue to explore empagliflozin’s potential to improve outcomes across these conditions and look forward to the forthcoming results of the EMPA-KIDNEY trial, which is investigating the potential of empagliflozin in treating 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[6],[7]
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 top of standard treatment, the efficacy and safety of once-daily empagliflozin compared to placebo were studied.
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 global mortality, resulting in up to 20 million deaths annually.[8]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 eight studies and two real-world studies, with EMPEROR reinforcing the alliance's long-term commitment to improving clinical outcomes for patients with cardio-renal-metabolic diseases. 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.[9],[10]Heart failure is a widespread condition, affecting more than 15 million people in Europe.[2]And globally, more than 60 million people, with the incidence rate expected to increase with the aging population.[11],[12]Heart failure is very common in patients with diabetes, but about half of the patients with heart failure do not have diabetes.[13]
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 interconnected conditions that affect more than 1 billion people worldwide and are a leading cause of death.
Cardiovascular, Renal and Metabolic Systems Are Interconnected with Shared Risk Factors and Pathological Pathways in Disease Spectrum[14],[15],[16]
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. It is also the first type 2 diabetes medication to include data on reducing the risk of cardiovascular death in the prescribing information across many countries.[17],[18]
References
[1] Health Policy Partnership. Heart failure policy and practice in Europe. Available at: https://www.healthpolicypartnership.com/app/uploads/Heart-failure-policy-and-practice-in-Europe.pdf Accessed: February 2022.
[2] Andersen MJ, Borlaug BA. Heart failure with preserved ejection fraction: current understandings and challenges. Curr Cardiol Rep. 2014 Jul;16(7):501.
[3] Butler J, Fonarow G, Zile M, et al. Developing therapies for heart failure with preserved ejection fraction: Current State and Future Directions. JACC Heart Fail. 2014 Apr;2(2):97–112.
[4] Shah SJ, Borlaug B, Kitzman D, et al. Research priorities for heart failure with preserved ejection fraction. Circulation. 2020;141:1001–26
[5] 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.
[6] 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: February 2022.
[7] 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: February 2022.
[8] 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. Lancet. 2016; 388(10053):1459–544.
[9] American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: February 2022.
[10] 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: February 2022.
[11] Lippi G, Sanchis-Gomar F. Global epidemiology and future trends of heart failure. AMJ. 2020;5:15
[12] Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019;124(1):121–41.
[13] 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.
[14] 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.
[15] García-Donaire JA, Ruilope LM. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol. 2011;2011:975782.
[16] 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: February 2022.
[18] Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: February 2022.