Sanofi-Aventis wins FDA approval for diabetes drug

The approval of Apidra for pediatric use is based upon FDA review of a 26-week, Phase III, open-label, active control study of Apidra in comparison with insulin lispro, in 572 children and adolescents (four years and older) with type 1 diabetes.

Apidra has a rapid onset and short duration of action and should normally be used in combination with longer-acting or basal insulin. Apidra can also be used in insulin infusion pump therapy for blood sugar control, the company said.

Michelle Baron, vice president of metabolism medical unit at Sanofi-Aventis US, said: “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.

“We are pleased that the fast onset of action and mealtime dosing flexibility of Apidra will now be available to children four years and older.”