Apidra approved for paediatric use in the US
This article was originally published in Scrip
Executive Summary
The US FDAhas approvedSanofi-Aventis's rapid-acting insulin analogue Apidra (insulin glulisine) for improving glycaemic control in children four years and older with diabetes mellitus. Apidra is already available in the US for use in adults with types 1 and 2 diabetes. The expanded approval was based on data from a 26-week, Phase III open-label, active-control study in 572 children and adolescents aged over four years with type 1 diabetes. Other rapid-acting insulins already approved for use in children in the US include Lilly's Humulin R and Novo Nordisk's Novolog (insulin aspart). Apidra was approved in the EU in July for use in children aged six years and older (Scrip Online, July 28th, 2008).