Novo Nordisk (NVO) recently announced that the U.S. Food and Drug Administration (:FDA) expanded the label of its diabetes drug, Levemir (insulin detemir [rDNA origin] injection). Levemir, a long-acting insulin analogue, received approval for type I diabetes in children between two to five years of age.
According to data provided by the Centers for Disease Control and Prevention (:CDC), over 13,000 young people are diagnosed with type I diabetes, annually. The youngest of these children are at maximum risk of experiencing severe hypoglycemia and acute diabetes complications. Levemir is the first basal insulin analogue to be approved for treatment in such a young population. We feel that this label expansion will boost sales of the drug.
The approval was based on data, which demonstrated that efficacy of Levemir was at par with neutral protamine Hagedorn (:NPH) insulin in type I diabetic children between two to five years of age.
Levemir is already approved in the U.S. for use in type I diabetes patients above 5 years and type II diabetes patients above 18 years.
Last month, Levemir was approved for use in pregnant women with diabetes with category B classification. It was found that the use of Levemir did not increase the risk of harm to the unborn baby.
Our Recommendation
We have a Neutral recommendation on Novo Nordisk. The stock carries a Zacks #3 Rank (Hold rating) in the short term.
So far, we are impressed by the performance of Victoza, which is doing well both in the U.S. and Europe. Moreover, we believe that the next-generation insulin analogues, Tresiba and Ryzodeg, hold significant potential for long-term growth at Novo Nordisk. Though we are encouraged by data from the Tresiba trials, we prefer to remain on the sidelines until Tresiba and Ryzodeg gain approval.
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