Clinical data published recently in Pediatric Diabetes showed that Novo Nordisk’s (NVO) lead basal insulin analogue, Levemir, is as effective as human basal insulin in the treatment of type I diabetes in pediatric patients aged two to five years. Levemir was also associated with less hypoglycemic risk.
The data showed that Levemir in combination with a fast acting insulin analogue, NovoRapid (another drug of Novo Nordisk), led to a lower rate of all-day and nocturnal hypoglycaemia against those taking human basal insulin plus NovoRapid. None of the patients treated with Levemir had a severe hypoglycemic episode, whereas three patients treated with human basal insulin experienced episodes of hypoglycemia.
Novo Nordisk is working to update the label to include the data. If the label update is successful, Levemir will become the first drug to be approved for treatment in such a young population.
Children under the age of six years are at maximum risk of experiencing severe hypoglycemia and acute diabetes complications. As such, the Levemir label, if updated, could boost sales of the drug.
Levemir’s biggest competitor is Sanofi Aventis’ (SNY) Lantus.
Our Recommendation
We currently have a Neutral recommendation on Novo Nordisk, which is supported by a Zacks #3 Rank (short-term “Hold” recommendation). We are impressed by Novo Nordisk’s biggest drug Victoza’s performance so far. Moreover, we believe that the diabetes pipeline candidates, Degludec and DegludecPlus, also hold key importance for long-term growth at Novo Nordisk. Though we are encouraged by the phase III data from Degludec trials, we prefer to remain on the sidelines until we get more visibility on the approvability of Degludec and DegludecPlus.
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