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news.The FDA has approved Novo Nordisk Levemir (insulin detemir [rDNA origin] injection) for use in children with type 1 diabetes.
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The basal insulin analog is approved for type 1 diabetes patients from age two through adulthood and adult patients with type 2 diabetes.
Pediatric Diabetes Editor-in-Chief Mark Sperling said, "Levemir, with its approval from the FDA, is a particularly welcome addition to our treatment options for some of our youngest patients with type 1 diabetes."
The approval was based on data that showed that Levemir is an equally efficacious treatment option for two- to five-year-old children (n=82) with type 1 diabetes, compared with Neutral Protamine Hagedorn (NPH) insulin.
The study observed that no patients treated with Levemir had a severe hypoglycemic episode, whereas there were six reported episodes in three patients treated with NPH.