Novo Nordisk's Levemir approved for children ages 2 to 5 years

FDA expands approved uses of basal insulin product

PRINCETON, N.J. — The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years.

Drug maker Novo Nordisk announced Tuesday the additional approval of Levemir (insulin detemir [rDNA origin]). The insulin already was approved for Type 1 diabetes in older children and adults and Type 2 diabetes in adults, and the drug maker said the new FDA approval made Levemir the only basal insulin analog for use in the 2 to 5 year age group.

"Our biggest challenges and top priorities when treating some of the youngest children with Type 1 diabetes are safety and reducing the risk of hypoglycemia," said, Mark Sperling, editor-in-chief of the journal Pediatric Diabetes, referring to low blood sugar. "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."


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