European Commission approves new insulin analog for control of diabetes in children

The approval of APIDRA for pediatric use provides children (6 years and older) with the option of using APIDRA as part of their overall diabetes treatment plan, usually in combination with a 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 pre-meal) in 572 children and adolescents with Type 1 diabetes.

"Sanofi-aventis recognizes the many challenges faced by children with diabetes and their families, and is committed to providing pediatric patients and their healthcare providers with new treatment options," said Dr. Riccardo Perfetti, Senior Medical Director, Diabetes-Metabolism Franchise, Sanofi-aventis. "With the rapid-acting APIDRA insulin analog, we hope to offer patients an effective treatment of choice for their overall diabetes therapy."

Dr. Hisham Mahmoud, Medical Director of Sanofi-aventis Gulf, said,

"No less than 5 GCC countries rank their current diabetes prevalence among the world's 10 highest, including the UAE, where overall prevalence of the disease is estimated at over 20%. This clearly indicates the need for effective new measures to tackle the threat of diabetes, especially among children, since there has been a dramatic rise in juvenile diabetes cases across the Gulf region."

APIDRA works fast and offers flexible insulin dosing to help manage mealtime blood sugar levels, and should be administered shortly (0-15 min) before or soon after the meal. As parents often need to administer to their child insulin until he or she is able to administer insulin injections on their own, this new indication for APIDRA provides children (6 years and older) and their parents with a new option for treating diabetes, particularly of using APIDRA SoloSTAR to administer APIDRA. APIDRA SoloSTAR is easy to use and provides pediatric patients and their caregivers with a convenient option for delivering accurate APIDRA doses.

APIDRA has a rapid onset and short duration of action which allows covering the postprandial hyperglycemic peaks. It should normally be used in combination with a long-acting or basal insulin to cover the fasting and interprandial hyperglycemia. APIDRA can also be used alone in insulin infusion pump therapy for blood sugar control.

Diabetes (diabetes mellitus) refers to a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. Diabetes is characterized by abnormally high concentrations of glucose in the blood. Diabetes treatments are aimed at lowering glucose levels in the blood, in order to delay the appearance of complications. Insulins are given as a substitute (Type 1) or a supplement (Type 2) to natural insulin secretion.