Novo Nordisk announced that the FDA has approved Levemir (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes. This expansion now makes Levemir the first and only basal insulin analog available for use in this young patient group.

The FDA approval was based on data that showed Levemir as an equally efficacious treatment option for two- to five-year-old children (n=82) with type 1 diabetes, compared with NPH insulin. Mean HbA1c was similar between groups (Levemir 8.2% vs. NPH 8.1% at baseline, and 8.1% vs. 8.3%, respectively, at one year).

Levemir, a man-made long-acting insulin, is now indicated for patients with type 1 diabetes from ages two through adulthood and for adult patients with type 2 diabetes.

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