Novo Nordisk has presented data which it says supports use of its diabetes drug Levemir in children aged two to five.
The Danish drugmaker noted that the data, published in Pediatric Diabetes, show that Levemir (insulin detemir) is an equally efficacious treatment option for two to five year-old children with type 1 diabetes, compared with human basal insulin, but is associated with lower hypoglycaemic risk.
The company noted that no basal insulin analogue is currently recommended for these young children, and it is now working to update the Levemir label. Novo quoted Nandu Thalange, of the Norfolk and Norwich University Hospital, UK, as saying that "unfortunately, children with type 1 diabetes who are aged under six years have the greatest likelihood of severe hypoglycaemia and the highest risk of acute diabetes complications.
This is why "it is especially important to examine the safety for this very young age group", he added, saying the results suggest clinically relevant safety benefits of Levemir.
Kirstine Brown Frandsen, corporate vice president of global medical affairs at Novo, said that if the application for a label update is successful, Levemir will also be the second of the company's insulin analogues, after NovoRapid (insulin aspart), that will cover this very young patient population.