Jardiance® (empagliflozin) approved in the EU for the treatment of adults with chronic kidney disease 

The European Commission (EC) approved Jardiance^® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD)⁸, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. The approval has the potential to advance the standard of care for more than 47 million people in the EU living with CKD,² and help relieve burden on healthcare systems by reducing the risk of all-cause hospitalization for people with CKD.^5,9,10 With existing indications in type 2 diabetes and heart failure,⁶ empagliflozin could help manage the risks of cardio-renal-metabolic conditions, which are often interconnected. Cardio-renal-metabolic conditions affect over 1 billion people worldwide.⁷

“We celebrate this significant milestone in the field of chronic kidney disease. CKD is a silent killer and prevention and early detection are crucial in the general population," said Daniel Gallego, President of European Kidney Patients’ Federation. "This new treatment option has the potential to further improve the management of cardiorenal metabolic syndrome and renal disease, offering renewed hope and improved quality of life for countless individuals living with CKD worldwide.” 

The approval is based on results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date, which showed a significant benefit of empagliflozin in reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent vs. placebo in people with chronic kidney disease (HR; 0.72; 95% CI 0.64 to 0.82; P<0.000001 [absolute risk reduction 3.8%]). The trial also demonstrated a statistically significant relative risk reduction in hospitalization for any cause by 14 percent vs. placebo (HR; 0.86; 95% CI 0.78 to 0.95; p=0.0025 [absolute risk reduction 4.4%]).^4,5 The overall safety data was generally consistent with previous findings, confirming the well-established safety profile of empagliflozin.^4,5 CKD doubles a person’s risk for hospitalization³ and is a leading cause of death globally.² In the EU, hospitalizations account for up to 70 percent of total healthcare costs for people with CKD.^9,10 

“Living with chronic kidney disease can have a drastic impact on patients and their family’s lives. CKD not only affects individuals but also society overall due to the high economic burden to healthcare systems,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “As we deepen our knowledge in interconnected cardio-renal-metabolic conditions, we are very excited about the approval and the potential for empagliflozin to play an essential role in helping patients, their physicians and healthcare systems.”

“CKD is closely linked to other cardio-renal-metabolic conditions such as type 2 diabetes and heart failure – thus an integrated approach is vital for optimized treatment of these interconnected conditions. We look forward to continuing conversations with other regulatory bodies worldwide so that empagliflozin can be made available for as many people living with these conditions as quickly as possible,” continued Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly.

About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin^4,5,11

EMPA-KIDNEY (NCT03594110) is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk. EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date.⁵ It included 6,609 participants across a wide range of underlying causes, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. EMPA KIDNEY results demonstrate that empagliflozin may benefit adults at risk of kidney disease progression, including those with or without diabetes, and across a wide range of kidney function. The primary outcome is defined as time to a first event of either cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as dialysis or kidney transplantation), a sustained decline in eGFR to <10 mL/min/1.73 m², kidney death, or a sustained decline of ≥40 percent in eGFR from randomization. Key secondary outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality. EMPA-KIDNEY includes 6,609 adults randomized from eight countries with established chronic kidney disease both with and without diabetes, as well as with and without albuminuria, receiving either empagliflozin 10 mg or placebo, on top of current standard of care.

About chronic kidney disease

Chronic kidney disease affects approximately 850 million people worldwide which is more than 10 percent of the population.¹ The condition is caused by progressive damage to the kidneys that prevents them from working as well as they should. With it mostly being asymptomatic (no symptoms) until later stages of the condition, most people go undiagnosed and every year millions die prematurely from chronic kidney disease and related complications.^12,13,14 The Boehringer Ingelheim and Lilly Alliance are committed to transforming care for people with chronic kidney disease and other cardio-renal-metabolic conditions. 

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 1 billion people worldwide and are a leading cause of death.⁷ 

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum.¹⁴ 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, improvements in one system can lead to positive effects throughout the others.^15,16,17

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 for people with type 2 diabetes and cardiovascular disease in its label in several countries.^18,19 Empagliflozin is indicated in the EU in adults with type 2 diabetes, heart failure and most recently chronic kidney disease.⁶

Boehringer Ingelheim and Eli Lilly and Company

The Boehringer Ingelheim and Lilly Alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate their commitment, not only to the care of people with type 2 diabetes, but also to address areas of unmet medical need like heart failure and chronic kidney disease.

About Boehringer Ingelheim 

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. 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, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.

About Lilly 

Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit lilly.com and lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn.

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 Jardiance® as a treatment for adults with chronic kidney disease 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 Jardiance^® 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:

Harro ten Wolde
Global Head of Media Relations
Boehringer Ingelheim
Email: harro.ten_wolde@boehringer-ingelheim.com

Kristiane Bello
Lilly Diabetes Communications
Eli Lilly and Company
Email: bello_kristiane@lilly.com

References

1. Li P, et al. Braz J Med Biol Res. 2020; 53(3): e9614.
2. Bikbov B, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733.
3. USRDS. 2021 Annual Report. Available at: https://usrds-adr.niddk.nih.gov/2021/chronic-kidney-disease/3-morbidity-and-mortality-in-patients-with-ckd. Accessed: July 2023.
4. EMPA-KIDNEY full data presentation, presented on 4 November 2022 at the American Society of Nephrology (ASN) Congress 2022 - Kidney Week.
5. Herrington W, Staplin N, Wanner C, et al. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023; 388:117-127.
6. EMC. Jardiance 10 mg film-coated tablets. Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/5441/smpc#gref. Accessed: July 2023.
7. Schechter, M. et al. Cardiovasc Diabetol. 2022:21;104.
8. https://ec.europa.eu/health/documents/community-register/html/h930.htm
9. Turchetti G, Bellelli S, Amato M, et al. The social cost of chronic kidney disease in Italy. Eur J Health Econ. 2017;18(7):847-858.
10. Gandjour A, Armsen W, Wehmeyer W, Multmeier J, and Tschulena U. Cost of patients with chronic kidney disease in Germany. 2020. PLOS ONE 15(4): e0231375.https://doi.org/10.1371/journal.pone.0231375. 
11. Clinical Trials. EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin). Available at: https://clinicaltrials.gov/ct2/show/NCT03594110. Accessed: July 2023.
12. Coresh J. Update on the Burden of CKD. J Am Soc Nephrol. 2017;28(4):1020–1022.
13. Luyckx V, et al. Bull World Health Organ. 2018;96(6):414–422D.
14. Usman M, et al. Chronic Kidney Disease and Type 2 Diabetes. Arlington (VA): American Diabetes Association; 2021.Available at: https://professional.diabetes.org/sites/default/files/media/ada-ckd_compendium_fin_3_5-26-21_web2.pdf. Accessed: July 2023.
15. 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.
16. García-Donaire A, Ruilope M. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol. 2011:975782.
17. Leon M, Maddox M. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World J Diabetes. 2015;6(13):1246–58.
18. 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: July 2023.
19. Jardiance^® (empagliflozin) tablets, U.S. Prescribing Information Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: July 2023.