FDA expands use of Levemir (Novo Nordisk) for Type 1 Diabetic children

The FDA has approved Levemir (insulin detemir [rDNA origin] injection), from Novo Nordisk, for expanded use in children ages two to five years with Type 1 Diabetes. 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. The decision 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. Mean HbA1c was similar between groups (Levemir 8.2% vs. NPH 8.1% at baseline, and 8.1% vs. 8.3%, respectively, at one year). 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. In September 2011, the European CHMP similarly adopted a positive opinion on the extended use of Levemir in children ages two to five years with Type 1 Diabetes.