Aventis will wait to launch the rapid-acting recombinant human insulin analogue Apidra until after the company's OptiClick delivery device is approved by FDA.

Aventis submitted OptiClick for FDA approval in February 2004, the company says in a ¹ 20-F filing with the Securities & Exchange Commission. That timeline would indicate that FDA would make a decision on the OptiClick application by year-end.

Apidra (insulin glulisine injection) was approved April 16 for the "treatment of adult patients with diabetes mellitus for the control of hyperglycemia."

The current indication is for administration by subcutaneous injection or continuous subcutaneous pump infusion. However, Aventis is waiting until the more convenient delivery device is approved before launching Apidra.

Apidra will be marketed as a treatment for blood sugar spikes associated with meals. Apidra is designed to be injected within 15 minutes before a meal or within 20 minutes of starting a meal.

The company plans to promote Apidra using the same sales representatives as its long-lasting insulin Lantus (insulin glargine injection). Aventis has predicted that Apidra could reach peak sales of €400 mil. ($480 mil.).

- Lee Kalowski

Aventis Apidra Clears FDA; Rapid-Acting Insulin Launch Awaits Delivery Device Approval

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