Novo Nordisk’s new prefilled insulin pen receives Health Canada approval

20 October 2013 (Last Updated October 20th, 2013 18:30)

Novo Nordisk Canada has obtained Health Canada approval for its Levemir FlexTouch, a disposable prefilled insulin pen containing Levemir (insulin detemir), designed for treating patients with type 1 and type 2 diabetes.

flextouch

Novo Nordisk Canada has obtained Health Canada approval for its Levemir FlexTouch, a disposable prefilled insulin pen containing Levemir (insulin detemir), designed for treating patients with type 1 and type 2 diabetes.

FlexTouch is the only prefilled insulin pen that features an easy touch button and a spring-loaded mechanism.

The spring-loaded mechanism in the FlexTouch ensures that no matter how high the dose required, the push button does not extend and only a minimum of pressure is needed to deliver the dose.

As a result, the injection force of FlexTouch is significantly lower than other widely used prefilled pens.

Levemir FlexTouch improves ease of use for insulin administration and helps decrease barriers to good treatment adherence for Canadians living with type 1 and type 2 diabetes.

Rigorous clinical testing also showed that the new FlexTouch pen accurately and consistently delivers insulin doses.

Levemir (insulin detemir) is a long-acting basal insulin analogue sterile injection solution indicated for the treatment of adult patients with type 1 or type 2 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycaemia.

It is also used in the treatment of paediatric patients with type 1 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycaemia. However, the safety and efficacy of Levemir has not been studied in children below the age of six years.

In addition, the insulin detemir is used in the treatment of type 2 diabetes mellitus in combination with oral anti-diabetic (OAD) agents in adult patients who are not in adequate metabolic control on OADs alone.

According to the company, Levemir is also used in 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.

In 2012, Novo Nordisk obtained Health Canada approval for its NovoRapid FlexTouch, which provided Canadians living with diabetes with the first pre?lled insulin pen without a push-button extension for NovoRapid (insulin aspart).

"The approval of Levemir FlexTouch can help to address these barriers for those prescribed a long-acting basal insulin, resulting in improved treatment adherence."

The LMC Endocrinology Centre, Thornhill, Ontario co-director Dr Robert Schlosser said insulin treatment regimens can present challenges for many Canadians living with type 1 or type 2 diabetes.

"The approval of Levemir FlexTouch can help to address these barriers for those prescribed a long-acting basal insulin, resulting in improved treatment adherence," Dr Schlosser said.

Research indicates that insulin pens with relatively low injection force have been rated as easier and more comfortable to use by people with diabetes.

The company anticipates Levemir FlexTouch to be available in Canada in January 2014.

Approximately three million Canadians live with diabetes, with 10% suffering from type 1 diabetes and and 90% from type 2.

According to GlobalData estimates, the insulin pens market in Canada was valued at $101.8m in 2012 and is expected to grow at a CAGR of 3.7% to reach $132m by 2019.


Image: Disposable prefilled insulin pen. Photo: courtesy of Novo Nordisk A/S.