FDA Approves Levemir^® for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes

Levemir^® Is Now the First and Only Basal Insulin Analog Approved for Use in Patients as Young as Two

Princeton, N.J. (May 22, 2012) – Novo Nordisk, a world leader in diabetes care, announced today that 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. 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 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.¹ The youngest of these children with type 1 diabetes have the greatest likelihood of severe hypoglycemia and the highest risk of acute diabetes complications.²

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).³ 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.⁴

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).³ No patients treated with Levemir^® had a severe hypoglycemic episode, whereas there were six reported episodes in three patients treated with NPH over the one year study period.³

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.³

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.

For more information, visit www.levemir-us.com.