Novo Nordisk obtains FDA clearance for insulin dose system

3 November 2013 (Last Updated November 3rd, 2013 18:30)

Novo Nordisk has obtained US Food and Drug Administration (FDA) clearance for its prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch.

flextouch

Novo Nordisk has obtained US Food and Drug Administration (FDA) clearance for its prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch.

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.

Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: "Novo Nordisk is committed to continuously developing new and better solutions within insulin delivery, and this approval is an important milestone in the efforts to make the lives of people with diabetes easier."

NovoRapid is the most prescribed rapid-acting insulin analogue worldwide while Levemir is a long-acting basal insulin analogue sterile injection solution, both have been developed by Novo Nordisk.

NovoLog FlexTouch contains 300 units of insulin aspart and doses in one unit increments, from one to 80 units.

Levemir FlexTouch also contains 300 units of insulin detemir and the pen doses in one unit increments, from one to 80 units.

Both pens are compatible with NovoFine and the latest NovoTwist needles.

"NovoRapid is the most prescribed rapid-acting insulin analogue worldwide while Levemir is a long-acting basal insulin analogue sterile injection solution."

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

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

Novo Nordisk plans to make FlexTouch available in the US within the next year.

FlexTouch was approved by the European Commission in July 2011 and has been launched in several countries including the UK, Denmark and Japan.

NovoRapid FlexTouch was launched in Canada in May 2012 and Levemir FlexTouch launch is expected to be launched in January 2014.

According to GlobalData estimates, the insulin pens market in the US was valued at $670m in 2012 and is expected to grow at a CAGR of 5.5% to reach $976m by 2019.


Image: The new prefilled insulin pen with no push-button extension. Photo: courtesy of Novo Nordisk A/S.