EMPA-KIDNEY trial showed significant benefit of JARDIANCE® (empagliflozin) in reducing kidney disease progression or cardiovascular death by 28% vs. placebo in people living with chronic kidney disease

• EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease, provides new evidence for patients commonly seen in clinical practice^1,2,3
• Phase III trial also demonstrated a 14% statistically significant reduction in hospitalization for any cause^1,2

BURLINGTON, ON and TORONTO, Nov. 4, 2022 /CNW/ - EMPA-KIDNEY Phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for people living with chronic kidney disease (CKD).^1,2 When treated with empagliflozin, the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.001).^1,2 The results were announced today during the American Society of Nephrology (ASN)'s Kidney Week 2022 by the Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford which designed, conducted and analyzed EMPA-KIDNEY, in scientific collaboration with Boehringer Ingelheim, and Eli Lilly and Company (NYSE: LLY). The results were also published simultaneously in The New England Journal of Medicine.²

EMPA-KIDNEY is the first SGLT2 inhibitor trial in CKD to demonstrate a 14% significant reduction in all-cause hospitalizations (HR; 0.86; 95% CI 0.78 to 0.95; P=0.0025) vs. placebo as a pre-specified key secondary confirmatory endpoint.^1,2 CKD doubles a person's risk for hospitalization⁴ and is the tenth leading cause of death in Canada.⁵

The overall safety data were generally consistent with previous findings, confirming the well-established safety profile of empagliflozin.

"The EMPA-KIDNEY trial results provide new evidence to help treat people with chronic kidney disease who are commonly seen in clinical care but who have been under-represented in previous clinical trials – especially those with lower kidney function and lower urine albumin excretion," says Dr. David Cherney, EMPA-KIDNEY Steering Committee Member and Senior Scientist at Toronto General Hospital Research Institute. "Today's positive trial results across a broad chronic kidney disease patient population demonstrate that empagliflozin may benefit adults at risk of progression, including those with and without diabetes, and across a wide range of kidney function."

EMPA-KIDNEY 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 in people living with CKD. The EMPA-KIDNEY trial is the largest and broadest dedicated SGLT2 inhibitor trial to date in chronic kidney disease.³ It included 6,609 participants across a wide range of people living with CKD, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. The trial assessed both kidney and cardiovascular outcomes in people across the spectrum of CKD severity.⁶

One in 10 Canadians are living with kidney disease,⁷ and more than 50,000 are being treated for kidney failure symptoms.⁷ The leading cause of kidney disease in Canada is diabetes.⁸ Up to one-half of people living with diabetes demonstrate signs of renal damage in their lifetime.⁸ 

"The Boehringer Ingelheim and Lilly Alliance is incredibly proud that EMPA-KIDNEY has provided another pivotal moment for empagliflozin," said Carinne Brouillon, Head of Human Pharma and Member of the Board of Managing Directors, Boehringer Ingelheim. "Today's data adds to the body of evidence from our clinical program which includes more than 700,000 adults with cardiovascular, kidney and metabolic conditions. EMPA-KIDNEY reinforces the potential role of empagliflozin in changing the way these interconnected conditions may be managed."

"Today's EMPA-KIDNEY trial results will be welcomed by people living with CKD and the medical community. We are also encouraged by the risk reduction for hospitalization after just two years, as this finding is in line with the significant reductions seen in prior empagliflozin cardiovascular outcomes trials," says Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "The Alliance looks forward to discussing plans for marketing authorization for CKD with regulators worldwide in due course."

Notes to editors
Kidney disease progression: Defined as end-stage kidney disease (the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decline in estimated glomerular filtration rate (eGFR) to below 10 mL/min/1.73 m², kidney death or a sustained decline of at least 40 percent in eGFR from randomization).

End stage kidney disease: Includes initiation of maintenance dialysis or receipt of a kidney transplant

About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin in people living with CKD^1,2,3
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 in people living with CKD. 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 CKD 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 the Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford
The MRC PHRU at the University of Oxford, part of Oxford Population Health, improves the treatment and prevention of chronic diseases, particularly cardiovascular disease and metabolic disease (such as diabetes mellitus and CKD), which collectively account for a large proportion of premature adult deaths and the burden of disability worldwide. MRC PHRU is led by EMPA-KIDNEY Steering Committee co-chair Professor Colin Baigent. MRC PHRU coordinates innovative clinical trials and meta-analyses that have a major impact on health. Other major studies include the ground-breaking Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial which is co-led by EMPA-KIDNEY Steering Committee co-chair, Professor Sir Martin Landray. MRC PHRU's worldwide approach, involving the study of large numbers of people, provides reliable information about the causes of disease and the effects of treatments, and has had a major impact on global health.

About the EMPOWER program
The Boehringer Ingelheim and Lilly Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and kidney outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.⁹ Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-kidney-metabolic conditions. With more than 700,000 adults enrolled worldwide, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.¹⁰ 

About empagliflozin
Empagliflozin (marketed as Jardiance^®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first treatment to include cardiovascular death risk reduction data in people living with type 2 diabetes and established cardiovascular disease in its label in several countries.^11,12,13 Empagliflozin is the first and only approved treatment to improve outcomes of people living with heart failure regardless of ejection fraction.¹⁴

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need.

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.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.ca. 

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

CONTACTS:

Anne Coffey 
Specialist, Brand Communications  
Boehringer Ingelheim (Canada) Ltd. 
Email: [email protected]  

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

References

^{__________________________________
1}  EMPA-KIDNEY full data presentation, presented on 4 November 2022 at the American Society of Nephrology (ASN) Congress 2022 - Kidney Week.

² Herrington, W.G. et al. Empagliflozin in Patients with Chronic Kidney Disease, N Engl J Med, online publication on November 4, 2022, at NEJM.org. DOI: 10.1056/NEJMoa2204233.

³ EMPA-KIDNEY Collaborative Group. Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. Nephrol Dial Transplant. 2022 Jun 23;37(7):1317-1329.

⁴ USRDS. 2021 Annual Report. [online] (Accessed October 2022).

⁵ Statistics Canada. Leading causes of death in Canada, 2019. Retrieved from: https://www150.statcan.gc.ca/n1/daily-quotidien/201126/t001b-eng.htm. (Accessed October 2022). 

⁶ Clinical Trials. EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin). Available at: https://clinicaltrials.gov/ct2/show/NCT03594110 (Accessed October 2022)

⁷ Kidney Foundation. Facing The Facts. Retrieved from: https://kidney.ca/KFOC/media/images/PDFs/Facing-the-Facts-2020.pdf. (Accessed October 2022)

⁸ 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 October 2022)

⁹ 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.

¹⁰ Boehringer Ingelheim and Eli Lilly and Company. Data on file. 2022.

¹¹ 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 October 2022)

¹² Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. (Accessed October 2022)

¹³ Jardiance Product Monograph. Boehringer Ingelheim (Canada) Ltd. April 6, 2022. Retrieved from: https://www.boehringer-ingelheim.ca/sites/ca/files/documents/jardiancepmen.pdf (Accessed October 2022)

¹⁴ Boehringer Ingelheim. (2022, April 12). Jardiance^® (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction [Press release]. https://www.boehringer-ingelheim.ca/en/press-release/jardiance-empagliflozin-becomes-first-and-only-approved-treatment-canada-adults (Accessed November 2022)

SOURCE Boehringer Ingelheim (Canada) Ltd.