Sanofi-aventis announced that the European Commission approved Apidra (insulin glulisine [rDNA origin] injection), a rapid-acting insulin analog, for the control of hyperglycaemia in adolescents and children (6 years and older) with diabetes mellitus.
The approval of Apidra for paediatric use provides children (6 years and older) with the option of using Apidra as part of their overall diabetes treatment plan, usually in combination with a basal insulin. The approval is based upon review of a 26-week, phase III, open-label, active control study of Apidra in comparison with Humalog (both administered premeal) in 572 children and adolescents with type 1 diabetes.
Apidra works fast and offers flexible insulin dosing to help manage mealtime blood sugar levels, and should be administered shortly (0-15 min) before or soon after the meal. As parents often need to administer to their child insulin until he or she is able to administer insulin injections on their own, this new indication for Apidra provides children (6 years and older) and their parents with a new option for treating diabetes, particularly of using Apidra SoloSTAR to administer Apidra. Apidra SoloSTAR is easy to use and provides paediatric patients and their caregivers with a convenient option for delivering accurate Apidra doses.
"Sanofi-aventis recognizes the many challenges faced by children with diabetes and their families, and is committed to providing paediatric patients and their healthcare providers with new treatment options, "said Riccardo Perfetti, MD PhD, senior medical director, Diabetes-Metabolism Franchise, sanofi-aventis.
"Now the rapid-acting insulin analog Apidra will be available to children 6 years and older with diabetes, and we hope it will offer them an effective treatment of choice for their overall diabetes therapy."
Apidra has a rapid onset and short duration of action which allows covering the postprandial hyperglycaemic peaks. It should normally be used in combination with a long-acting or basal insulin to cover the fasting and interprandial hyperglycaemia. Apidra can also be used alone in insulin infusion pump therapy for blood sugar control.
Lantus is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia and for adult and paediatric patients (6 years and older) with type 1 diabetes mellitus. Lantus demonstrates a relatively peakless and sustained concentration/time profile over 24 hours thus reducing the risk of hypoglycaemia and allowing a constant and high efficacy over 24h with one single daily injection.
Apidra is a rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adults and now for adolescents and children (6 years and older) with diabetes in the EU. Apidra offers patients mealtime dosing flexibility-it can be taken shortly (0-15 min) before or soon after the meal. Apidra is also flexible for use in a wide range of patients from lean to obese. Apidra is an optimised partner to Lantus once prandial insulin is required.
SoloSTAR allows administering doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR offers a 25% greater maximum capacity than other disposable insulin pens, up to 80 units of insulin in one injection. SoloSTAR uses a simple, intuitive design with an easy-to-read display, and requires only a few steps to use it properly. SoloSTAR is small, discreet and eliminates the need for the patient to change insulin cartridges. Easy-to-use and easy-to-inject, SoloSTAR reduces the injection force by 30% or more in comparison to other most broadly available pens in its class. A recent survey of Lantus SoloSTAR used in everyday clinical practice, involving more than 2000 people with diabetes (16% with manual dexterity problems and 15% with poor eyesight not corrected by glasses) showed that more than 95% of participants declared to be "satisfied" or "very satisfied" with using SoloSTAR to inject insulin, irrespective of diabetes type or previous device experience.
Lantus SoloSTAR and Apidra SoloSTAR were approved by the European Commission in September 2006; Lantus SoloSTAR was approved by the FDA in April 2007. Lantus SoloSTAR and Apidra SoloSTAR are launched in France, UK, Italy, Spain, Germany, Netherlands, Slovakia, Slovenia, Sweden, Norway, Iceland, Poland, Austria, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Australia, Lithuania, Lebanon, South Africa, and Switzerland. Lantus SoloSTAR is launched in the US, Canada, Japan and India. The preparation for launches in other countries is planned during 2008.