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FDA Approves Apidra for Use With Children

The FDA has approved the fast-acting insulin Apidra (insulin glulisine) for use in children four years and older who have type 1 diabetes. 

Apidra, manufactured by sanofi-aventis, is a rapid-acting insulin that can be administered via an insulin infusion pump, vial and syringe, insulin pen, or intravenously. Users typically inject it within 15 minutes before or 20 minutes after the start of a meal.   

The drug is usually used in conjunction with longer-acting basal insulin.

Approval for its use with children came after FDA review of a 26-week, phase III study in which Apidra’s effects were compared with those of insulin lispro in 572 children at least four years old. 

The study compared changes in A1c from Apidra and insulin lispro and found that statistically, the difference between the two drugs was near zero. 

The incidence of hypoglycemia, which is the most common adverse reaction to insulin, was 7.2 percent in the Apidra users and 8.1 percent in the lispro group. 

The addition of Apidra to the arsenal of insulins and insulin-like drugs available to treat children comes at an opportune time. Worldwide, the number of children 14 years old or younger with type 1 diabetes is estimated at 440,000, with 70,000 new cases diagnosed each year. In the United States, type 1 diabetes is the most common type of diabetes in children, with approximately 176,500 people under 20 years of age affected by the disease.

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