FDA Approves Novo Nordisk's Levemir(R) For Treatment Of Diabetes In Children
PRINCETON, N.J., Oct. 20 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir(R) (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 change(1). 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 chance(2).
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.
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.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. With the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems, Novo Nordisk is a world leader in diabetes care. In the United States, Novo Nordisk's ambition is Changing Diabetes. Working as a catalyst to improve diabetes prevention and treatment, the company strives to be the preferred partner for employees, patients, healthcare providers, and others in the healthcare system who share its vision to defeat diabetes. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs approximately 21,000 full-time employees in 78 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit www.novonordisk.com; for United States information, visit www.novonordisk-us.com.
Levemir is a registered trademark of Novo Nordisk A/S. (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.Photo: http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGONovo Nordisk Inc.
CONTACT: Media - Susan Jackson, +1-609-919-7776, or Investors - MadsVeggerby Lausten, +1-609-919-7937, both for Novo Nordisk Inc.