Novo Nordisk (NYSE:NVO) has received approval from the U.S. Food and Drug Administration to expand its type 1 diabetes drug Levemir to children as young as 2 years old.
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.
Novo Nordisk originally received FDA approval for Levemir in 2005 and more recently got approval for its use for pregnant women with diabetes.
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.
By Stephanie Baum
Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.Visit website | More posts by Author
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