Novo Nordisk gains US FDA approval for FlexTouch insulin pens

Danish insulin giant Novo Nordisk (NOV: N) announced on Friday that the US Food and Drug Administration has approved the prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch.

Also, Levemir FlexTouch has just been approved by the Canadian health authorities, Health Canada, the company noted.

FlexTouch is the latest innovation in prefilled insulin delivery systems from Novo Nordisk. When a dose is dialled with traditional prefilled pens, the push button extends, and at larger doses this can present challenges for the patient. The spring-loaded dosing mechanism of FlexTouch ensures the push button does not extend at any dose and patients can easily -deliver their insulin dose with just a touch of a button.

"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," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

NovoRapid already most-prescribed rapid-acting insulin analogue

NovoRapid (insulin aspart) is the most prescribed rapid-acting insulin analogue worldwide, generating sales of 12.39 billion Danish kroner ($2.29 billion) in the first nine months of 2013 (The Pharma Letter October 31). Levemir (insulin detemir), with sales in that period reaching 8.38 billion kroner, is a long-acting basal insulin, both have been developed by Novo Nordisk.

Novo Nordisk plans to make FlexTouch available in the USA within the next year. FlexTouch was approved by the European Commission in July 2011 and launched in several countries including the UK, Denmark and Japan during the last couple of years. NovoRapid FlexTouch was launched in Canada in May 2012.