Sanofi-aventis has received approval for Apidra (insulinglulisine [rDNA origin] injection) to improve glycemic control in children agedfour years and older with diabetes mellitus.
The clearance for pediatric use isbased on FDA review of a 26-week, phase 3, open-label study of Apidra in 572children and adolescents with type 1 diabetes. Study results showed that thedrug was as effective as insulin lispro.
Apidra is a rapid-acting insulin thatoffers flexible dosing to help manage mealtime blood sugar levels. It should beadministered within 15 minutes before or within 20 minutes after the start of ameal and should normally be used in combination with a longer-acting or basalinsulin.
“Sanofi-aventis is committed to providing children with diabetes, aswell as their families and health-care providers, safe and effective treatmentoptions to help address the challenges associated with the condition and tohelp decrease the long-term risk for devastating complications of diabetes,”said Michelle Baron, MD, vice president, Metabolism Medical Unit,Sanofi-aventis US.