FDA Approves Sanofi’s Apidra in Additional Indication

The FDA has approved Sanofi-Aventis’ insulin product Apidra for intravenous administration under medical supervision in a clinical setting for adult patients with type 1 and type 2 diabetes.

Apidra is already approved for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. In addition to intravenous use, when treating type 1 or type 2 diabetes patients with hyperglycemia in a clinical setting, Apidra can be administered subcutaneously in vial form, insulin pen, or external insulin infusion pump, Sanofi said.

The FDA based its decision on results from a randomized, open-label, two- way crossover study of 16 healthy male subjects who received an intravenous infusion of Apidra or regular human insulin with saline diluent at a rate of 0.8 IU/kg/min for two hours. Infusion of the same dose of Apidra or regular human insulin produced equivalent glucose disposal at steady state.