The approval of Apidra for pediatric use provides children with the option of using Apidra as part of their overall diabetes treatment plan, usually in combination with basal insulin.
The approval is based upon review of a 26-week, Phase III, open-label, active control study of Apidra in comparison with Humalog (both administered premeal) in 572 children and adolescents with type 1 diabetes. Apidra can also be used alone in insulin infusion pump therapy for blood sugar control.
Riccardo Perfetti, senior medical director of diabetes-metabolism franchise at Sanofi-Aventis, said: “Now the rapid-acting insulin analog Apidra will be available to children six years and older with diabetes, and we hope it will offer them an effective treatment of choice for their overall diabetes therapy.”