Novo Nordisk wins FDA approval for two automated-dose insulin pens

Novo Nordisk's NovoLog FlexTouch insulin pen--Courtesy of Novo

Danish diabetes care giant Novo Nordisk ($NVO) won FDA approval this week for two of its FlexTouch prefilled insulin pens, NovoLog and Levemir.

Novo's line of FlexTouch pens is the first with a spring-loaded dosing mechanism, which allows delivery at the touch of a button as opposed to a manually guided dose. Novo developed the idea based on patient feedback for its FlexPen, which uses the more standard delivery method, and studies had shown a high preference for the new device.

As for what makes FlexTouch stand apart from other pens on the market: "First of all, it is the no push-button extension … with a very low dose force needed and 80 units being the max dose," wrote a company spokesperson in an email to FierceDrugDelivery. "In addition, the end-of-dose click gives patient confidence in accurate dose delivery. There is also the clear color differentiation for easy insulin identification. Lastly, the injection speed is controlled and constant from injection to injection under similar conditions."

The NovoLog and Levemir pens deliver fast-acting and basal doses, respectively, for both children and adults. With the pens approved in the EU in 2011 and launched in countries such as the U.K., Canada, Denmark and Japan, the company plans to make both available in the U.S. this year.

"Novo Nordisk is committed to continuously introducing new solutions that can improve the lives of people with diabetes," said Novo Executive VP and Chief Scientific Officer Mads Krogsgaard Thomsen in a statement. "This approval marks another advancement in insulin delivery and an important milestone for Novo Nordisk."

In the vast U.S. diabetes market, however, insulin pens are beginning to take a backseat to more fully automated insulin pumps, which are becoming more and more advanced and reliable. And on the horizon for diabetics is the inauguration of the artificial pancreas, which combines a pump with a glucose monitor, being developed by several companies including Medtronic ($MDT), Johnson & Johnson ($JNJ), Becton Dickinson ($BD) and Tandem Diabetes Care.

- here's the release

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