Health Canada Approves new indication for JARDIANCE™ (empagliflozin) tablets for adults with type 2 diabetes and established cardiovascular disease

• Approval based on cardiovascular outcome clinical trial EMPA-REG OUTCOME^®, which demonstrated empagliflozin significantly reduced the incidence of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.¹

Canadian Media Only

BURLINGTON, ON AND TORONTO, Aug. 11, 2016 /CNW/ - Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada Inc. announced today that Health Canada has approved a new indication for JARDIANCE™ (empagliflozin), as an adjunct to diet, exercise and standard care therapy, to reduce the incidence of cardiovascular (CV) death in patients with type 2 diabetes and established CV disease who have inadequate glycemic control.¹

JARDIANCE™ received an initial Notice of Compliance (NOC) from Health Canada on July 23rd, 2015, to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.¹ On July 27^th, 2016, based on data from the EMPA-REG OUTCOME^® trial, Health Canada approved the new indication to include adult patients with type 2 diabetes and established CV disease.¹

The lead clinical trial investigator, Dr. Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital; Senior Scientist, Lunenfeld-Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, presented the results of EMPA-REG OUTCOME^® at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting. The results were also published in New England Journal of Medicine (NEJM).²

"Worldwide, cardiovascular disease is the number one cause of death in people with type 2 diabetes," said Dr. Zinman.  "Addressing the burden of cardiovascular events, including cardiovascular death, is at the core of diabetes care. In this study, empagliflozin was shown to prevent one out of three cardiovascular deaths. These results are encouraging for healthcare professionals and their patients with type 2 diabetes and cardiovascular disease. The Canadian Diabetes Association has revised their guidelines to reflect these new and exciting research findings."

About EMPA-REG OUTCOME^® Trial

EMPA-REG OUTCOME^® is a long-term, multi-centre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries who had type 2 diabetes and established CV disease. There were 772 primary outcome events in the trial over a median observation period of 3.1 years.³

EMPA-REG OUTCOME^® is the CV outcome clinical trial designed to investigate the safety of empagliflozin in patients with type 2 diabetes and established CV disease. Results demonstrated empagliflozin achieved superiority for the primary composite endpoint of CV death, non-fatal heart attack, or non-fatal stroke (Major Adverse Cardiovascular events [MACE-3]), and a significant reduction in CV death in people with type 2 diabetes and CV disease at high risk of CV events.¹ In addition, treatment with empagliflozin resulted in a lower risk of all-cause mortality (32 per cent reduction) and hospitalization for heart failure (35 per cent reduction).¹

Empagliflozin significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 per cent when added to standard of care, in patients with type 2 diabetes and CV disease. There was a 38 per cent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.¹

The effect of empagliflozin in this trial was observed in addition to standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or CV disease (such as blood pressure and cholesterol-lowering medications).

The study assessed the effect of empagliflozin (10mg or 25mg once daily) added to standard of care compared with placebo in addition to standard of care. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. The study was designed to first test for non-inferiority and then for superiority.

Standard of care was comprised of glucose-lowering agents and CV drugs (including blood pressure and cholesterol-lowering medications).

Of the 7,020 treated patients, more than 97 per cent completed the trial and vital status was available for more than 99 per cent of these patients at study end. Analyses and results were independently validated and confirmed by the University of Freiburg in Germany, an internationally renowned research centre specializing in statistical analyses.

About type 2 diabetes and cardiovascular disease

Diabetes is a complex³ and chronic disease.⁴ Over eleven million Canadians are living with diabetes or prediabetes.⁵ Every three minutes, another Canadian is diagnosed.⁵ Approximately 90 per cent of people with diabetes have type 2 diabetes.⁵ The list of complications that diabetes patients face is long, and includes chronic kidney disease, blindness, and non-traumatic amputation.⁵

Cardiovascular disease is the leading cause of death in individuals with type 2 diabetes and approximately 75 per cent of patients with type 2 diabetes will die from it.^4,5

In Canada, heart disease and stroke are leading causes of death⁶ and hospitalization.⁷ An estimated 1.6 million Canadians are living with heart disease or the effects of a stroke.⁸ It is estimated that one person dies every 7 minutes from heart disease or stroke.⁸

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three pipeline compounds representing several of the largest treatment classes. This Alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. For more information about the Alliance visit www.boehringer-ingelheim.ca or www.lilly.ca.

About Boehringer Ingelheim (Canada) Ltd.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 145 affiliates and a total of more than 47,500 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of its net sales. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

For more information please visit www.boehringer-ingelheim.ca.

About Eli Lilly Canada Inc.

Lilly 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 those who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli 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. Lilly Canada now employs more than 500 people across the country, working in the areas of oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

^TM Trademark owned by Boehringer-Ingelheim; used under license.  JARDIANCE™ is co-promoted with Eli Lilly Canada. 

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¹ Jardiance Product Monograph. Boehringer Ingelheim (Canada) Ltd. (July 25, 2016)
² Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117–2128
³ Cheng A. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada: introduction. Can J Diabetes 2013;37(suppl 1):S1-S3.
⁴ Canadian Diabetes Association, 2016. Types of Diabetes. Available at: https://www.diabetes.ca/about-diabetes/types-of-diabetes
⁵ Mancini GBJ, Cheng AY, Connelly K, et al, Diabetes for Cardiologists:
Practical Issues in Diagnosis and Management, Canadian Journal of Cardiology (2016), doi: 10.1016/j.cjca.2016.07.512.
⁶ Statistics Canada, 2015. The 10 leading causes of death, 2012. Available at: http://www.statcan.gc.ca/pub/82-625-x/2015001/article/14296-eng.htm
⁷ Public Health Agency of Canada, 2009. Tracking Heart Disease and Stroke in Canada. Available at: http://www.phac-aspc.gc.ca/publicat/2009/cvd-avc/index-eng.php
⁸ Heart and Stroke Foundation of Canada, 2016. About us. Available at: http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3479075/k.C8B0/About_Us.htm

SOURCE Eli Lilly Canada Inc.

Jennifer Mota, Corporate Communications, Boehringer Ingelheim (Canada) Ltd., Email: [email protected], Phone: [phone]; Helen Stone, Manager, Communications, Eli Lilly Canada Inc., Email: [email protected], Phone: [phone]