Health Canada approves JARDIANCE^™ (empagliflozin) tablets for adults with type 2 diabetes

Burlington and Toronto, Ontario, Novemver 30, 2015 – Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada announced today that Health Canada has approved JARDIANCE^™ (empagliflozin) to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.¹

JARDIANCE^™ belongs to a new class of agents called sodium glucose co-transporter 2 (SGLT2) inhibitors that have a different mechanism of action from other oral glucose-lowering agents.² JARDIANCE^™ lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.¹

"Although there are many medications available for the treatment of type 2 diabetes, one in two people are not achieving the recommended glycemic goals," says Dr. Ronald M. Goldenberg, Endocrinologist at LMC Diabetes and Endocrinology in Thornhill, Ontario. "The approval and availability of JARDIANCE^™ gives Canadian physicians another option to help improve glycemic control."

Clinical study results using JARDIANCE^™
Empagliflozin was studied as a single agent (monotherapy) and in combination with other antidiabetic medications, including metformin, metformin and sulfonylurea, pioglitazone (with or without metformin), and basal and prandial insulin (with or without metformin).

Empagliflozin was also studied in patients with type 2 diabetes and cardiovascular disease, and in patients with different degrees of renal impairment.¹

Treatment with empagliflozin resulted in statistically significant improvements from baseline at Week 24 in HbA1c, fasting plasma glucose (FPG), and body weight across a range of background therapies. In the double-blind placebo-controlled extension of these studies, reductions of HbA1c and body weight were sustained up to Week 76. HbA1c reductions were also seen across subgroups including gender, age, race, duration of disease, and baseline BMI.¹

In clinical studies, the most common adverse event with empagliflozin was hypoglycaemia, which depended on the type of background therapy used in the respective studies. Other common adverse events included urinary tract infections, genital mycotic infections, increased urination, upper respiratory tract infections and dyslipidemia.¹

About JARDIANCE^™
JARDIANCE^™ is indicated for use:¹

Monotherapy: as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance.

Add-on combination: in adult patients with type 2 diabetes mellitus to improve glycemic control, when metformin used alone does not provide adequate glycemic control, in combination with metformin, metformin and a sulfonylurea, pioglitazone (alone or with metformin), basal or prandial insulin (alone or with metformin), when the existing therapy, along with diet and exercise, does not provide adequate glycemic control.

The recommended starting dose of JARDIANCE^™ is 10 mg once daily at any time of the day with or without food. The dose can be increased to 25 mg once daily for patients who require additional glycemic control and tolerate the 10 mg dose.¹

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 146 affiliates and a total of more than 47,700 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 the 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 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 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 more than 550 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, cardiovascular and endocrine disorders, men’s and women’s health, autoimmunity, neuroscience and diabetes. To learn more about Lilly Canada, please visit us at www.lilly.ca.