Insulin Glulisine for Pediatric Diabetes Cleared
Sanofi-aventis has received approval for Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children aged four years and older with diabetes mellitus.
The clearance for pediatric use is based on FDA review of a 26-week, phase 3, open-label study of Apidra in 572 children and adolescents with type 1 diabetes. Study results showed that the drug was as effective as insulin lispro.
Apidra is a rapid-acting insulin that offers flexible dosing to help manage mealtime blood sugar levels. It should be administered within 15 minutes before or within 20 minutes after the start of a meal and should normally be used in combination with a longer-acting or basal insulin.
“Sanofi-aventis is committed to providing children with diabetes, as well as their families and health-care providers, 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 US.