Apidra wins approval for use by children
Dubai, August 13, 2008
European Commission has approved Apidra, a rapid-acting insulin analog for the control of hyperglycemia in adolescents and children with diabetes, Sanofi-aventis has announced.
The approval of Apidra (insulin glulisine [rDNA origin] injection) for paediatric 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, it said.
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 recognises 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 five 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 per cent. 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, he said.
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, the statement said. – TradeArabia News Service