FDA Approves Apidra SoloSTAR – a Prefilled Disposable Insulin Pen

Apidra(R) SoloSTAR(R) is a convenient insulin delivery device to help patients with diabetes improve glycemic control.

Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) approved Apidra SoloSTAR(R) (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra(R), which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.

The approval of Apidra(R) SoloSTAR(R) follows the approval and launch of Lantus SoloSTAR(R)(insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus(R) and Apidra(R) to help manage their blood sugar will now have two pen delivery devices to make administration of their insulins convenient. Basal-prandial insulin regimens that combine once-daily Lantus(R) as a basal insulin analog with rapid-acting Apidra(R) at mealtime can closely mimic normal physiologic insulin secretion.

“Patients with diabetes have to contend with the challenges of carbohydrate counting, regular blood sugar monitoring and careful administration of their insulin,” said Angela Moskow, vice president, Metabolism Marketing, sanofi-aventis, U.S.. “Apidra(R) SoloSTAR(R) represents another innovation introduced by sanofi-aventis that offers patients a convenient option for administering their Apidra(R).”

Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very different types of insulins (rapid-acting vs. long-acting). The differentiation of the Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) was shown in a specific comparative study. Nevertheless, before using Apidra(R) SoloSTAR(R) or Lantus(R) SoloSTAR(R), patients should carefully examine the labeling on the pen, to ensure they are using the correct one. Apidra(R) SoloSTAR(R) operates with a low injection force.

Apidra(R) SoloSTAR(R) is expected to be available in pharmacies this year.

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