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Health Canada Approves Levemir® FlexTouch® Prefilled Insulin Pen For The Treatment Of Type 1 And Type 2 Diabetes

MISSISSAUGA, ON, Oct. 18, 2013 /CNW/ - Novo Nordisk today announced that Health Canada has approved Levemir ® FlexTouch ®, a disposable prefilled insulin pen containing Levemir ® (insulin detemir). Levemir ® FlexTouch ® has been designed to improve ease of use for insulin administration and to help decrease barriers to good treatment adherence for Canadians living with type 1 and type 2 diabetes mellitus (diabetes).

The approval was also announced at the 2013 Vascular Conference in Montreal, Quebec.

Levemir ® FlexTouch ® features a push-button that does not extend at any set dose and a unique spring-loaded mechanism, in which the injection is driven by a torque spring rather than the user's thumb pressure. 1  The torque spring is loaded as the dose is set and the spring energy is activated by depressing the push-button. As a result, the injection force of FlexTouch ® is significantly lower than other widely used prefilled pens. 2  In 2012, Novo Nordisk announced the Health Canada approval of NovoRapid ® FlexTouch ®, which provided Canadians living with diabetes with the first prefilled insulin pen without a push-button extension for NovoRapid ® (insulin aspart). 3

"Insulin treatment regimens can present challenges for many Canadians living with type 1 or type 2 diabetes, such as the convenience of insulin delivery, the anxiety associated with injections or the confidence in injection accuracy," 4 said Dr. Robert Schlosser, MD, FRCPC, Co-director of the LMC Endocrinology Centre, Thornhill, Ontario. "The approval of Levemir FlexTouch can help to address these barriers for those prescribed a long-acting basal insulin, resulting in improved treatment adherence."

Research indicates that insulin pens with relatively low injection force have been rated as easier and more comfortable to use by people with diabetes. 5  In clinical studies, FlexTouch ® was found to have design features and a functionality that make it an attractive device for insulin delivery. 6

It is anticipated that Levemir ® FlexTouch ® will be available in Canada in January 2014.

About FlexTouch ®: FlexTouch ® is a new disposable insulin injection pen device for use in insulin-treated patients with diabetes mellitus.  FlexTouch ® features a spring-loaded dosing mechanism, which means that the dose button does not extend at any dose and that patients can easily deliver their insulin dose with just a touch of a button. 7,8

About Levemir ® (insulin detemir): Levemir ® (insulin detemir) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analogue that is indicated for 9:
  • The treatment of adult patients with type 1 or type 2 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycemia.
  • The treatment of pediatric patients with type 1 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycemia. The safety and efficacy of Levemir ® has not been studied in children below the age of 6 years.
  • The treatment of type 2 diabetes mellitus in combination with oral anti-diabetic agents in adult patients who are not in adequate metabolic control on OADs alone.
  • The treatment of adult patients with type 2 diabetes mellitus in combination with Victoza ® (liraglutide) and metformin, when Victoza ® and metformin do not achieve adequate glycemic control. 9

More information about Levemir ® can be found in the product monograph, available at www.novonordisk.ca.

About NovoRapid ® (insulin aspart): NovoRapid ® (insulin aspart) is indicated for treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia.  NovoRapid ® should normally be used in regimens together with an intermediate or long-acting insulin.

NovoRapid ® differs from regular human insulin by its rapid onset and shorter duration of action.  As a result of the fast onset of action, the injection of NovoRapid ® should immediately be followed by a meal.  As a result of the short duration of action of NovoRapid ®, patients with diabetes may also require a longer-acting insulin to maintain adequate glucose control.

More information about NovoRapid ® can be found in the product monograph, available at www.novonordisk.ca.

About Diabetes in Canada: Diabetes is a life-long, often debilitating and sometimes fatal disease in which the body either cannot produce insulin or cannot properly use the insulin it produces. This leads to high levels of glucose in the blood, which can damage organs, blood vessels and nerves. 1  Type 1 diabetes is an autoimmune disease that occurs when the pancreas no longer produces insulin or produces very little insulin.  Type 2 diabetes occurs when the pancreas does not produce enough insulin to meet the body's needs, or the body is unable to respond properly to the actions of insulin. 11

In Canada, approximately three million people are living with diabetes. 12  Ten per cent of these live with type 1 diabetes, and 90 per cent live with type 2. 13  The cost of diabetes to Canada's healthcare system and economy was $11.7 billion in 2010, which is projected to increase to $16 billion annually by 2020. 14

About Novo Nordisk Canada Inc. Novo Nordisk is a healthcare company and a world leader in diabetes care and biopharmaceuticals. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. For more information, visit www.novonordisk.ca.

References: ___________________________

[1] Oyer et al. Expert Opinion on Drug Delivery, 2011;8(10):1259-1269.  Pg 1260. [2] Oyer et al. Expert Opinion on Drug Delivery, 2011;8(10):1259-1269.  Pg 1260. [3] NovoRapid ® Product Monograph, 8 December 2011. [4] Schipper et al. Current Medical Research & Opinion, 2012;28(8):1297-1303 [5] Oyer et al. Expert Opinion on Drug Delivery, 2011;8(10):1259-1269.  Pg 1260. [6] Schipper et al. Current Medical Research & Opinion, 2012;28(8):1297-1303 [7] Oyer et al. Expert Opinion on Drug Delivery, 2011;8(10):1259-1269.  Pg 1260. [8] Schipper et al. Current Medical Research & Opinion, 2012;28(8):1297-1303 [9] Levemir ® Product Monograph, 16 September 2013. [10] "Leading the Fight", Canadian Diabetes Association.  Accessed October 5, 2013.  Available at http://www.diabetes.ca/about-us/leading-the-fight/. [11] "Leading the Fight", Canadian Diabetes Association.  Accessed October 5, 2013.  Available at http://www.diabetes.ca/about-us/leading-the-fight/. [12] "Leading the Fight", Canadian Diabetes Association.  Accessed October 5, 2013.  Available at http://www.diabetes.ca/about-us/leading-the-fight/. [13] "Leading the Fight", Canadian Diabetes Association.  Accessed October 5, 2013.  Available at http://www.diabetes.ca/about-us/leading-the-fight/. [14] "Leading the Fight", Canadian Diabetes Association.  Accessed October 5, 2013.  Available at http://www.diabetes.ca/about-us/leading-the-fight/.

SOURCE Novo Nordisk Canada Inc.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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