Approval for rapid-acting insulin extended to children with diabetes

November 4, 2005

The FDA in September approved the supplemental new drug application of NovoLog, a rapid acting form of insulin for the control of hyperglycemia in patients with type 1 and type 2 diabetes. Manufactured by Novo Nordisk Inc., NovoLog can be administered immediately before a meal.

The FDA in September approved the supplemental new drug application of NovoLog, a rapid acting form of insulin for the control of hyperglycemia in patients with type 1 and type 2 diabetes. Manufactured by Novo Nordisk Inc., NovoLog can be administered immediately before a meal.

"The incidence of both type 1 and type 2 diabetes is increasing in children," explained Peter Aurup, MD, vice president of clinical development, medical and regulatory affairs at Novo Nordisk. "Approximately one in every 400 to 500 children and adolescents have type 1 diabetes. The approval of this new indication is a tremendous advance for members of the medical community who treat diabetes in young children."

Within minutes of entering the bloodstream, NovoLog begins to lower the blood glucose level. Rapid onset and short duration of action mimic the insulin action of a person without diabetes.

NovoLog is available in the prefilled NovoLog FlexPen insulin delivery system and is approved for use in insulin pumps. It is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin. Hypoglycemia is the most common adverse effect. The injectable was originally approved by the FDA in 2000 for use in adults.