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FDA Approves Levemir for Treatment of Diabetes in Children

Princeton, N.J. (October 20, 2005) – Novo Nordisk Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for use in children. Levemir is a novel, long-acting form of insulin that provides up to a 24-hour duration of action and has been observed in studies with adults to cause little weight change1. Novo Nordisk will launch Levemir for adults and children within the next eight months.

The U.S. diabetes epidemic continues to grow at an alarming rate. Research shows that a male born in 2000 has almost a 1 in 3 chance of developing diabetes during his lifetime and females fare even worse with a 2 in 5 chance2.

According to Peter Aurup, M.D., Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, "Our pediatric data further enhances the already strong product profile of Levemir, making it an important new treatment option for patients in both the pediatric and adult age ranges with this devastating disease."

Levemir was studied in a randomized, controlled clinical study of 347 children and adolescents with Type 1 diabetes. The children were treated with Levemir as the baseline or "basal" insulin and with rapid acting insulin (NovoLog) as a premeal (bolus) insulin for 26 weeks. At the conclusion of the study, Levemir was found to be both safe and effective.

About Diabetes in Children
Approximately one in every 400 to 500 children and adolescents has type 1 diabetes. According to the American Diabetes Association, the risk of developing type 1 diabetes is higher than virtually all other severe chronic diseases of childhood. Peak incidence occurs during puberty, around 10 to 12 years of age in girls and 12 to 14 years of age in boys. The symptoms of type 1 diabetes can mimic the flu in children.

About Levemir
Levemir is a soluble, long-acting basal insulin analogue. Levemir is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. Levemir has already been approved for use in 53 countries worldwide, including countries throughout Europe. Levemir was cleared for marketing in adults by the U.S. Food and Drug Administration in June 2005.

Hypoglycemia is the most common adverse effect of insulin therapy, including Levemir. Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash. Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients.

References:
1. The clinical significance of the latter has not been established.

2. Narayan, KMV, et al. Lifetime Risk for Diabetes Mellitus in the United States. JAMA 2003; 290: 1884-1890.

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