The US Food and Drug Administration (FDA) has approved Novo Nordisk's, a world leader in diabetes care, Levemir (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes. With the expansion of its paediatric indication, Levemir is now available for type 1 diabetes patients from age two through adulthood and adult patients with type 2 diabetes.

The FDA approval now makes Levemir the first and only basal insulin analog for use in this young patient 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 Dr. Mark Sperling, MD, Editor-in-Chief of Pediatric Diabetes. "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."

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.

The FDA 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 per cent.

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 the study, a slightly lower proportion of patients receiving Levemir reported adverse events than those receiving NPH (69.0% vs. 77.5%); the majority was considered unlikely related to the trial product. The most common severe adverse events (Levemir group: 12%, NPH group: 15%) were infections (gastroenteritis) and gastrointestinal disorders (dyspepsia) in both treatment groups.

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.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy.