Sanofi-Aventis announces European approval for Apidra

Sanofi-Aventis has announced the European Commission has granted approval for Apidra (insulin glulisine [rDNA origin] injection) as a treatment for the control of hyperglycemia in children and adolescents with diabetes mellitus.

The rapid-acting insulin analogue provides children with the option of using the compound as part of their overall treatment plan for their condition, usually in conjunction with a basal insulin.

Apidra has a rapid onset and short duration of action to cover postprandial hyperglcemic peaks and is used together with basal insulin or long-acting insulin to cover interprandial and fasting hyperglycemia.

It has been approved following a review of a 26-week phase III open-label active control study of Apidra in comparison with Humalog.

The company said the approval of the drug enables parents to use the “convenient” SoloStar system to administer the compound.

Riccardo Perfetti, senior medical director of the diabetes-metabolism Franchise at Sanofi-Aventis, said: “Sanofi-Aventis recognises the many challenges faced by children with diabetes and their families and is committed to providing paediatric patients and their healthcare providers with new treatment options.”

Last month, Sanofi-Aventis announced the results of a new study showing Apidra to be non-inferior to insulin lispro in terms of efficiency.