Empagliflozin (Jardiance®) receives MHRA approval for the treatment of heart failure with reduced ejection fraction

Empagliflozin (Jardiance^®) receives MHRA approval for the treatment of heart failure with reduced ejection fraction

• Heart failure is one of the leading causes of avoidable hospitalisations in the UK[i]
• Heart failure with reduced ejection fraction refers to heart failure with left ventricular ejection fraction (LVEF) <40% [ii]
• This new indication is based on the EMPEROR-Reduced trial [iii] which showed a significant 25% reduction (absolute risk reduction (ARR) 5.2%) in the combined relative risk versus placebo of cardiovascular death or hospitalisation for heart failure with reduced ejection fraction in adults with or without diabetes and an eGFR of ≥20ml/min/1.73 m²
• Empagliflozin was first approved in May 2014 for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Bracknell, UK, 2 September 2021 – Boehringer Ingelheim and Eli Lilly and Company are pleased to announce that the Medicines and Healthcare Products Regulatory Agency (MHRA) has now granted marketing authorisation for the use of empagliflozin (Jardiance^®) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction in the UK.[iv] The announcement follows the recent marketing authorisation granted by the European Commission on 17 June 2021.[v]

“This approval provides an important new treatment option which can now help the thousands of people with symptomatic chronic heart failure with reduced ejection fraction in the UK,” said Mark Petrie, Professor of Cardiology in the Institute of Cardiovascular and Medical Sciences at the University of Glasgow.“1.25 million hospital visits in England alone include a heart failure diagnosis as the cause or contributing factor. Providing new treatment options may help to address this pressure on the health service and benefit patients living with the impact of heart failure on their daily lives.”

Marketing authorisation is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25% reduction (ARR 5.2%) in the combined relative risk versus placebo of cardiovascular death or hospitalisation due to heart failure.3 The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes.3 Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalisation for heart failure by 30% (ARR 8.7%) and significantly slowed kidney function decline.3 Safety data from EMPEROR-Reduced was consistent with the known safety profile from previous trials and post marketing experience.[vi]   

“Approximately 200,000 new cases of heart failure are diagnosed in the UK each year and it remains a common cause of hospital admissions,” said Dr Douglas Clark, Head of Medical Affairs for UK and Ireland at Boehringer Ingelheim. “We look forward to working with national regulatory authorities to make empagliflozin available for the thousands of people living with heart failure.”

Heart failure is often associated with other diseases of the cardio-renal-metabolic systems such as type 2 diabetes and kidney disease.[vii]^,[viii]^,[ix] Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others.7^,8,9 Heart failure is very common[x] and can be a severe complication of a heart attack[xi] and occurs when the heart cannot pump sufficient blood to the rest of the body.[xii] Heart failure with reduced ejection fraction means the heart cannot contract normally.[xiii] People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.[xiv]^,[xv]

[i] British Heart Foundation. Heart failure: A Blueprint for Change Report. Available at: https://www.bhf.org.uk/-/media/files/health-intelligence/heart-failure-a-blueprint-for-change.pdf?la=en&rev=f89dedb7c933452e8086cc063ff98c26&hash=98E3BEADD6A46974EF0AAD86044B8DC5314F4E2B Accessed: June 2021.

[ii] 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. The Task Force for the diagnosis and treatment of acute and chronic heart failure of the ESC. Eur Heart J. 2016; 37, 2129–2200

[iii] 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.

[iv] MHRA Latest documents. Available at: https://www.gov.uk/government/latest?departments%5B%5D=medicines-and-healthcare-products-regulatory-agency

[v] EC Public Health. Union Register of Medicinal Products. Adopted Commission Decisions of the Last Six Months. Jardiance. Available at: https://ec.europa.eu/health/documents/community-register/html/reg_last.htm                 Last accessed July 2021

[vi] Jardiance® (empagliflozin) tablets SmPC. Available at: https://www.medicines.org.uk/emc/product/5441/smpc#gref Last updated on emc: 4 August 2021. Last accessed August 2021

[vii] García-Donaire JA and Ruilope LM. 2011. Cardiovascular and Renal Links along the Cardiorenal Continuum. International Journal of Nephrology. 2011:975782.

[viii] Leon BM and Maddox TM. 2015. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World Journal of Diabetes. October 10; 6(13): 1246-1258.

[ix] Thomas CM, Cooper ME, and Zimmet P. 2015. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nature Reviews Nephrology. 12, pages73–81 (2016)

[x] Bragazzi NL, Zhong W, Shu J et al. Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017. European Journal of Preventive Cardiology, zwaa147. Available at: https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa147/6133248 Accessed July 2021

[xi] Anderson JL and Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017;376:2053–64.

[xii] 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.

[xiii] 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 July 2021.

[xiv] 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.

[xv] 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.