PRINCETON, N.J., Sept. 15 /PRNewswire/ -- Novo Nordisk Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of NovoLog(R) (insulin aspart [rDNA origin] injection) for the treatment of diabetes in children. NovoLog(R) is a rapid-acting insulin analogue which can be administered immediately before a meal. The FDA approval comes approximately 4 months before the agency's review deadline.
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"The incidence of both type 1 and type 2 diabetes is increasing in children," said Peter Aurup, M.D., Vice President of Clinical Development, Medical, and Regulatory Affairs, Novo Nordisk Inc. "Approximately one in every 400 to 500 children and adolescents has type 1 diabetes. The approval of this new indication is a tremendous advance for the medical community who treat diabetes in children. NovoLog is now recognized as a new, effective and well tolerated option for these young patients," he added.
NovoLog was studied for use in children and adolescents with diabetes ranging in age from two to 18. In these studies, NovoLog was found to be both safe and effective.
About Diabetes in Children(1)
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. The symptoms of type 1 diabetes can mimic the flu in children.
Additionally, a growing number of children and adolescents are developing type 2 diabetes -- a form of diabetes that is generally diagnosed among adults.
NovoLog is a rapid acting form of insulin for the treatment of patients with diabetes mellitus (type 1 and type 2) for the control of hypoglycemia. It enters the bloodstream quickly and begins working within minutes to lower blood glucose. The rapid onset and short duration of action mimic the insulin action of a person without diabetes. NovoLog offers convenient mealtime dosing and should be dosed immediately or up to 10 minutes before a meal. NovoLog is available in the prefilled NovoLog FlexPen(TM) insulin delivery system and is approved for use in insulin pumps.
NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin aspart or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog. See package insert for more details.
NovoLog was originally approved by the FDA for use in adults in the U.S. in 2000.
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 is 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 http://www.novonordisk.com; for United States information, visit http://www.novonordisk-us.com.
1. Diabetes Statistics For Youth, American Diabetes Association Fact Sheet
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