Jardiance® (empagliflozin) receives authorization from Health Canada for the treatment of adults with chronic kidney disease

BURLINGTON, ON and TORONTO, Jan. 23, 2024 /CNW/ - Health Canada has authorized Jardiance^® (empagliflozin) to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular and renal death in adults with chronic kidney disease (CKD),¹ Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada Inc. announced today. The authorization has the potential to advance the standard of care for more than 4 million people in Canada living with CKD.² Along with existing metabolic and cardiovascular indications, Jardiance^® can now help manage patients across the spectrum of cardio-renal-metabolic conditions.

"This new treatment option has the potential to further improve the clinical care for people living with CKD by reducing the risk of kidney function loss, kidney failure, cardiovascular death and hospitalizations," says Dr. David Cherney, EMPA-KIDNEY Steering Committee Member, Canadian co-National Lead Investigator and Senior Scientist at Toronto General Hospital Research Institute. "Given the interconnectedness of cardio-renal-metabolic conditions, it is beneficial to have medicines that target the heart, kidney and endocrine system in one treatment."

One in 10 Canadians are living with kidney disease, and more than 50,000 are being treated for kidney failure symptoms.³ Diabetes is the leading cause of kidney disease and up to one-half of people living with diabetes develop signs of renal damage in their lifetime.⁴

The authorization by Health Canada is supported by the results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date.⁵ Jardiance^® 10 mg was superior in reducing the risk of the primary composite endpoint of sustained ≥40% eGFR decline, sustained eGFR <10 mL/min/1.73m², ESKD, renal death or CV death compared with placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.001 [absolute risk reduction 3.8%]).⁶ Additionally, Jardiance^® 10 mg significantly reduced the risk of all-cause hospitalization, (first and recurrent) by 14% compared with placebo (HR; 0.86; 95% CI 0.78 to 0.95; P=0.003 [absolute risk reduction 4.4%]).⁶

"Living with chronic kidney disease can have a drastic impact on the lives of patients and their families. CKD not only affects individuals but also society overall due to the high economic burden to healthcare systems," says Dr. Rasha Eldesouky, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim Canada. "As we deepen our knowledge of the interconnected cardio-renal-metabolic conditions, we are very excited about the potential for Jardiance^® to play an essential role in helping patients, their physicians and the Canadian healthcare system."

"Following previous indications for Jardiance^® in heart failure and type 2 diabetes, this label expansion provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression," says Dr. Alexander (Sandy) Henderson, Associate Vice President, Medical Affairs, Lilly Canada. "This milestone adds to the legacy of the Boehringer Ingelheim and Lilly Alliance to advance treatment options for people with a range of interconnected cardio-renal-metabolic conditions."

About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin^6,7
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. The primary outcome is defined as time to a first event of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m², a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes. Key secondary outcomes include a composite of hospitalization for heart failure or cardiovascular death, all-cause hospitalization, and all-cause mortality. EMPA-KIDNEY includes 6,609 adults from eight countries with CKD, both with and without diabetes, who were randomized to receive either empagliflozin 10 mg or placebo, once daily, both 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 per cent of the population.⁸ The condition is caused by progressive damage to the kidneys that prevents them from working as well as they should.⁹ 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.^9,10,11,12 The Boehringer Ingelheim and Lilly Alliance is committed to transforming care for people with chronic kidney disease and other cardio-renal-metabolic conditions.

About cardio-renal-metabolic conditions
The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum.^13,14 Dysfunction in one system may accelerate worsening outcomes of the other systems, 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.^13,15,16 Conversely, improvements in one system can lead to positive effects throughout the others.¹⁶

Boehringer Ingelheim and Lilly are driven to transform care for people living with cardio-renal-metabolic conditions. 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.¹ Empagliflozin is indicated in Canada in adults with type 2 diabetes, type 2 diabetes and established cardiovascular disease, heart failure and most recently chronic kidney disease.¹

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 (Canada) Ltd.
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 perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at www.boehringer-ingelheim.com/ca/.

About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.com/en-CA/.

For our perspective on issues in healthcare and innovation, follow us on Twitter at @LillyMedicalCA. 

CONTACTS: 

Anne Coffey 
Manager Human Pharma Communications
Boehringer Ingelheim (Canada) Ltd. 
Email: [email protected]

Amanda Meek
Stakeholder Engagement Manager
Lilly Canada
Email: [email protected]

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References

1 Jardiance Product Monograph. Boehringer Ingelheim (Canada) Ltd.

2 Bello A K, Ronksley P E, Tangri N, Kurzawa J, Osman M A, Singer A, Grill A, Nitsch D, Queenan J A, Wick J, Lindeman C, Soos B, Tuot D S, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney International Reports, 2019;4(4):561-570.

3 Kidney Foundation. Facing The Facts. Retrieved from https://kidney.ca/KFOC/media/images/PDFs/Facing-the-Facts-2020.pdf. Accessed January 2024.

4 Diabetes Canada. Chronic Kidney Disease in Diabetes. Retrieved from https://www.diabetes.ca/health-care-providers/clinical-practice-guidelines/chapter-29#panel-tab_FullText. Accessed January 2024.

5 EMPA-KIDNEY Collaborative Group. Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. Nephrol Dial Transplant. 2022;37(7):1317-1329.

6 The EMPA-KIDNEY Collaborative Group et al. Empagliflozin in Patients with Chronic Kidney Disease. The New England journal of medicine vol. 388,2 (2023): 117-127. doi:10.1056/NEJMoa2204233.

7 Clinical Trials. EMPA-KIDNEY (The Study of Heart and Kidney Protection with Empagliflozin). Available at: https://clinicaltrials.gov/ct2/show/NCT03594110. Accessed January 2024.

8 Li P, et al. Kidney health for everyone everywhere – from prevention to detection and equitable access to care. Braz J Med Biol Res. 2020; 53(3): e9614.

9 The Kidney Foundation of Canada (2023). What is Kidney Disease? Retrieved from https://kidney.ca/Kidney-Health/Newly-Diagnosed/What-is-Kidney-Disease. Accessed January 2024.

10 Coresh J. Update on the Burden of CKD. J Am Soc Nephrol. 2017;28(4):1020–1022.

11 Luyckx V, et al. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018;96(6):414–422D.

12 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: January 2024.

13 Schechter, M. et al. Epidemiology of the diabetes-cardio-renal spectrum: a cross-sectional report of 1.4 million adults. Cardiovasc Diabetol. 2022:21;104.

14 Ndumele, Chiadi E et al. "A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association." Circulation vol. 148,20 (2023): 1636-1664.

15 Ndumele, Chiadi E et al. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation vol. 148,20 (2023): 1606-1635.

16 Marassi, Marella, and Gian Paolo Fadini. The cardio-renal-metabolic connection: a review of the evidence. Cardiovascular diabetology vol. 22,1 195. 31 Jul. 2023.

SOURCE Boehringer Ingelheim (Canada) Ltd.