The long-acting recombinant human insulin analog marketed as Levemir has been approved for children aged 2-5 years with type 1 diabetes, the manufacturer has announced.
Levemir (insulin detemir [rDNA origin] injection) was previously approved for people with type 1 diabetes aged 6 years through adulthood and for the treatment of type 2 diabetes in adults.
The approval of the expanded pediatric indication was based on a study comparing Levemir with NPH insulin, which found that the two were as effective as was treatment with NPH insulin in terms of mean hemoglobain A1c values achieved at 1 year, according to the manufacturer, Novo Nordisk.
In patients with type 1 diabetes, Levemir is always used in combination with a rapid-acting insulin.
The updated prescribing information for Levemir is available at www.novo-pi.com/levemir.pdf and on the FDA's website.