Novo Nordisk’s Levemir Insulin Approved for Use in Children as Young as Two

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The U.S. Food and Drug Administration (FDA) has approved Levemir (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes, making it the first and only basal insulin analog for use in this young patient group. With the expansion of its pediatric indication, Levemir is now available for type 1 diabetes patients from age two through adulthood and adult patients with type 2 diabetes, as well as pregnant patients.

The FDA decision was based on data that showed that Levemir is an equally efficacious treatment option for two- to five-year-old children with type 1 diabetes, compared with Neutral Protamine Hagedorn (NPH) insulin. Mean HbA1c was similar between groups. According to 2012 American Diabetes Association guidelines, it is recommended that children younger than age six have an A1c goal of less than 8.5 percent. 

Each year, more than 13,000 young people are diagnosed with type 1 diabetes. The youngest of these children with type 1 diabetes have the greatest likelihood of severe hypoglycemia and the highest risk of acute diabetes complications. 

This pre-specified and stratified subgroup data showed that children with type 1 diabetes from ages two to five who received Levemir plus a rapid acting insulin analog, NovoLog (insulin aspart [rDNA origin] injection), experienced a low rate of hypoglycemia compared with those taking NPH and NovoLog (24-hour: 50.6 vs. 78.3 episodes per patient year). No patients treated with Levemir had a severe hypoglycemic episode, whereas there were six reported episodes in three patients treated with NPH.

In September 2011, the European Committee for Medicinal Products for Human Use (CHMP) similarly adopted a positive opinion on the extended use of Levemir in children ages two to five years with type 1 diabetes.

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