FDA Approves Apidra(R) SoloSTAR(R) Prefilled Disposable Insulin Pen

Thu, 02/26/2009 - 4:44am
Sanofi-aventisannounced today that the FDA approvedApidra(R) SoloSTAR(R) (insulin glulisine 1/8rDNA origin3/8 injection), a prefilleddisposable pen containing rapid-acting insulin analog Apidra(R), which isindicated to improve glycemic control in adults and children (4 years andolder) with type 1 diabetes or adults with type 2 diabetes. The approval of Apidra(R) SoloSTAR(R) follows the approval and launch ofLantus(R) SoloSTAR(R) (insulin glargine 1/8rDNA origin3/8 injection) in 2007.People living with diabetes who use both Lantus(R) and Apidra(R) to helpmanage their blood sugar will now have two pen delivery devices to makeadministration of their insulins convenient. Basal-prandial insulin regimensthat combine once-daily Lantus(R) as a basal insulin analog with rapid-actingApidra(R) at mealtime can closely mimic normal physiologic insulin secretion."Patients with diabetes have to contend with the challenges ofcarbohydrate counting, regular blood sugar monitoring and carefuladministration of their insulin," said Angela Moskow, Vice President,Metabolism Marketing, sanofi-aventis, U.S. "Apidra(R) SoloSTAR(R) representsanother innovation introduced by sanofi-aventis that offers patients aconvenient option for administering their Apidra(R)." The Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) pens are the result ofover four years of intensive development, and were designed in dialogue withpatients, nurses and doctors to meet their needs and the high standards of theindustry. Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) are designed withcompletely different colors to help patients differentiate between the twopens, 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 comparativestudy. Nevertheless, before using Apidra(R) SoloSTAR(R) or Lantus(R)SoloSTAR(R), patients should carefully examine the labeling on the pen, toensure they are using the correct one. Apidra(R) SoloSTAR(R) operates with alow injection force and two studies found that this delivery device requiredless injection force than the Novo Nordisk FlexPen and the Eli LillyHumulin/Humalog pen. Apidra(R) SoloSTAR(R) is expected to be available in pharmacies this year.



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