Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) approved Apidra(R) (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes mellitus.
The approval of Apidra(R) for pediatric use is based upon FDA review of a 26-week, phase III, open-label, active control study of Apidra(R) in comparison with insulin lispro, in 572 children and adolescents (4 years and older) with type 1 diabetes.
"Sanofi-aventis is committed to providing children with diabetes, as well as their families and healthcare providers, with safe and effective treatment options to help address the challenges associated with the condition and to help decrease the long-term risk for devastating complications of diabetes," said Michelle Baron, MD, vice president, Metabolism Medical Unit, sanofi-aventis U.S. "We are pleased that the fast onset of action and mealtime dosing flexibility of Apidra(R) will now be available to children 4 years and older."
Apidra(R) has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. Apidra(R) can also be used in insulin infusion pump therapy for blood sugar control.