FDA approves Apidra for pediatric use

October 31, 2008

The US Food and Drug Administration (FDA) has approved insulin glulisine (Apidra) to treat diabetes in children ages 4 and older, announced the drug's manufacturer, sanofi-aventis.

The US Food and Drug Administration has approved insulin glulisine (Apidra) to treat diabetes in children ages 4 and older, announced the drug's manufacturer, sanofi-aventis.

The approval is based on an FDA review of a 26-week, phase III, open-label study comparing Apidra with insulin lispro among 572 children ages 4 to 17 with type 1 diabetes. Changes in HbA1c were similar in both treatment groups (+0.10% for glulisine vs. +0.16% for lispro), as was postprandial glycemic control during endpoint.

Additionally, 7.2% of participants in the glulisine group and 8.1% of participants in the lispro group reported the adverse event of hypoglycemia, according to the manufacturer.