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Sanofi-aventis gets EC approval for Apidra

The European Commission has approved sanofi-aventis drug, Apidra, for the control of hyperglycemia in adolescents and children over six-years old with type I diabetes
The European Commission (EC) has approved sanofi-aventis drug, Apidra, for the control of hyperglycemia in adolescents and children over six-years old with type I diabetes.

Apidra, which has been developed for paediatric use, and can be used in combination with their standard basal insulin as part of their diabetes treatment plan. The EC granted sanofi-aventis approval for the drug after a review of a 26-week phase III, open-label, active control study which involved 572 children and adolescents with Type I diabetes.

"Sanofi-aventis recognises the many challenges faced by children with diabetes and their families," said Dr Riccardo Perfetti, senior medical director, diabetes-metabolism franchise at sanofi-aventis. "The rapid-acting insulin analog Apidra will be available to children 6 years and older with diabetes and we hope it will offer them an effective treatment of choice for their overall diabetes therapy."

Type I diabetes is the most severe form of the condition and causes the immune system to destroy the insulin-producing beta cells of the pancreas that regulate blood glucose. The international diabetes foundation estimates that there are 444,000 children globally with Type I diabetes and that there are 70,000 new cases diagnosed every year. Children diagnosed with the condition will need daily insulin injections for rest of their lives.

25th July 2008

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