The man-made insulin is the only basal insulin analog approved for children 2 to 5 years old, the company said in a statement. Basal dosage is the amount required to manage daily fluctuations in blood glucose levels.
The Danish company, which has U.S. headquarters in Princeton, New Jersey, received approval for the same indication from the European Committee for Medicinal Products for Human Use in September last year.
About 13,000 young people are diagnosed with type 1 diabetes. An article in the Journal of American Medicine said young children are more likely to suffer severe hypoglycemia and have the highest risk of acute diabetes complications.
Last month, the company said it would be expanding its U.S. operations with roughly 600 staff in primarily field sales roles in response to the growth in type 2 diabetes cases.