Approval of APIDRA® gives a shot-in-the-arm to treatment of diabetes, especially in countries like the UAE where diabetes prevalence is among the highest in the world
August 13, 2008, Dubai, UAE: - Sanofi-aventis announced yesterday that the European Commission has approved APIDRA® (insulin glulisine [rDNA origin] injection), a rapid-acting insulin analog for the control of hyperglycemia in adolescents and children (6 years and older) with diabetes.
The approval of APIDRA® for pediatric 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 pre-meal) in 572 children and adolescents with Type 1 diabetes.
"Sanofi-aventis recognizes the many challenges faced by children with diabetes and their families, and is committed to providing pediatric patients and their healthcare providers with new treatment options," said Dr. Riccardo Perfetti, Senior Medical Director, Diabetes-Metabolism Franchise, Sanofi-aventis. "With the rapid-acting APIDRA® insulin analog, we hope to offer patients an effective treatment of choice for their overall diabetes therapy."
Dr. Hisham Mahmoud, Medical Director of Sanofi-aventis Gulf, said, "No less than 5 GCC countries rank their current diabetes prevalence among the world's 10 highest, including the UAE, where overall prevalence of the disease is estimated at over 20 per cent. This clearly indicates the need for effective new measures to tackle the threat of diabetes, especially among children, since there has been a dramatic rise in juvenile diabetes cases across the Gulf region."
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 pediatric patients and their caregivers with a convenient option for delivering accurate APIDRA® doses.
APIDRA® has a rapid onset and short duration of action which allows covering the postprandial hyperglycemic peaks. It should normally be used in combination with a long-acting or basal insulin to cover the fasting and interprandial hyperglycemia. APIDRA® can also be used alone in insulin infusion pump therapy for blood sugar control.
Diabetes (diabetes mellitus) refers to a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. Diabetes is characterized by abnormally high concentrations of glucose in the blood. Diabetes treatments are aimed at lowering glucose levels in the blood, in order to delay the appearance of complications. Insulins are given as a substitute (Type 1) or a supplement (Type 2) to natural insulin secretion.
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About Type 1 Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. In patients with Type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas that regulate blood glucose. Since the pancreas can no longer produce insulin, people with Type 1 diabetes require daily injections of insulin for their entire lives.
The International Diabetes Foundation estimates the global number of children (14 years of age and younger) with Type 1 diabetes to be 440,000, with 70,000 newly diagnosed cases each year.
About APIDRA® (insulin glulisine [rDNA origin])
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.
About Sanofi-aventis
Sanofi-aventis is one of the world's leading pharmaceutical companies, ranking number one in Europe. Backed by a world-class R&D organization, Sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For further media information, please contact:
Dalia Aziz
Sanofi-aventis
Tel: 9714 - 4299200
Fax: 9714 - 4298255
Email: dalia.aziz@sanofi-aventis.com
Nabil Naim
Headline Public Relations
Tel: 9714 - 2289655 Ext 113
Fax: 9714 - 2282125
Email: nabil@headlinepr.com
© Press Release 2008
