JARDIANCE® (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction

• JARDIANCE^® is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for chronic heart failure¹
• Heart failure represents a significant, growing disease burden in Canada, with more than 100,000 new cases diagnosed each year²

BURLINGTON, ON and TORONTO, April 12, 2022 /CNW/ - Health Canada has granted marketing authorization for JARDIANCE^® (empagliflozin) 10 mg for the treatment of chronic heart failure in adults as an adjunct to standard of care therapy, Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada Inc. have announced.³ This approval establishes JARDIANCE^® as the first and only approved treatment to improve outcomes of heart failure patients regardless of ejection fraction, including both heart failure with reduced and preserved ejection fraction (HFrEF and HFpEF). JARDIANCE^® can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m².³

The Canadian market authorization follows the U.S. Food and Drug Administration (FDA)'s approval in February 2022 and the European marketing authorization in March 2022.

"The availability of this treatment brings new hope for patients with preserved ejection fraction, who are among the sickest of my heart failure patients. Until now there were no effective therapies to improve long-term outcomes and reduce hospitalization," says Dr. Shelley Zieroth, cardiologist and director of St. Boniface Hospital Heart Failure and Transplant Clinics in Winnipeg, MB, and a clinical investigator for the EMPEROR-Preserved trial. "This is a remarkable milestone for the heart failure community and it will have a meaningful impact on the healthcare system as a whole."

Heart failure is a chronic condition caused by the heart not functioning as it should or by a problem with its structure.² This can lead to fatigue, swelling in the legs and abdomen and shortness of breath.² Heart failure is on the rise with 750,000 Canadians living with the disease and more than 100,000 receiving a diagnosis each year.²  HFpEF has been described as the single largest unmet need in cardiovascular medicine based on its prevalence, high morbidity and mortality, and the absence of clinically-proven therapies to date.^4,5

This approval is based on results from the landmark EMPEROR-Preserved^® phase III trial, which investigated the effect of JARDIANCE^® 10 mg compared with placebo once daily, both on top of standard-of-care therapy, in 5,988 adults with heart failure with LVEF over 40%.¹ In the trial, JARDIANCE^® demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI; P<0.001) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. The benefit was generally consistent across LVEF subgroups based on the pooled EMPEROR studies.³

A key secondary endpoint analysis from EMPEROR-Preserved^® showed that JARDIANCE^® reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% (407/2997 events for JARDIANCE^® vs. 541/2991 for placebo, 0.73 HR, 0.61-0.88 95% CI; P<0.001).¹

"The EMPEROR-Preserved trial demonstrated breakthrough benefits for widely underserved patients living with heart failure with preserved ejection fraction," says Dr. Gabriel Kim, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. "Today's approval means these demonstrated benefits can now help address a significant unmet need for Canadian heart failure patients."

"Building on the indication for heart failure with reduced ejection fraction last year, this approval reinforces JARDIANCE as a treatment option across the full spectrum of heart failure," 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 cardiometabolic conditions."

About the EMPEROR Heart Failure Clinical Trials^6,7
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure trials are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, with or without diabetes, who are receiving current standard of care:

• EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).

• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 3,730, which included 36 study sites in Canada
• Completion: 2020

• EMPEROR-Preserved [NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).

• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 5,988, which included 35 study sites in Canada
• Completion: 2021

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 one billion people worldwide and are a leading cause of death.^8,9

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 treatment for type 2 diabetes to include cardiovascular death risk reduction data in its label in several countries.^3,10,11

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. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or 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.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. 

REFERENCES

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	^1 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.
	^2 Heart and Stroke Foundation. 2022 Spotlight on Heart Failure. Available at: https://heartstrokeprod.azureedge.net/-/media/pdf-files/canada/2022-heart-month/hs-heart-failure-report-2022-final.ashx?la=en&rev=245159ea1726419aaa6f71ae9e7692f3 Accessed March 2022.
	^3 Jardiance Product Monograph. Boehringer Ingelheim (Canada) Ltd. April 6, 2022.
	^4 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.
	^5 Shah SJ, Borlaug B, Kitzman D, et al. Research priorities for heart failure with preserved ejection fraction. Circulation. 2020;141:1001–26.
	^6 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 June 2021.
	^7 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 June 2021.
	^8 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858.
	^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 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. Last accessed: March 2022.
	^11 Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Last accessed: March 2022.

SOURCE Boehringer Ingelheim (Canada) Ltd.

Anne Coffey, Specialist, Brand Communications, Boehringer Ingelheim (Canada) Ltd., Email: [email protected]; Amanda Meek, Stakeholder Engagement Manager, Lilly Canada, Email: [email protected], Phone: [phone]