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Paris, France - October 29, 2008
FDA approves rapid-acting insulin Apidra® for treatment of children with diabetes
Sanofi-aventis announced today that the U.S. Food and Drug
Administration (FDA) approved Apidra® (insulin glulisine [rDNA origin] injection) to improve
glycemic control in children (4 years and older) with diabetes mellitus.
The approval of Apidra® for pediatric use is based upon FDA review of a 26-week, phase III,
open-label, active control study of Apidra® in comparison with insulin lispro, in 572 children and
adolescents (4 years and older) with type 1 diabetes.
“Sanofi-aventis is committed to providing children with diabetes, as well as their families and
healthcare providers, with safe and effective treatment options to help address the challenges
associated with the condition, and to help decrease the long-term risk for devastating
complications of diabetes,” said Michelle Baron, MD, vice president, Metabolism Medical Unit,
sanofi-aventis U.S. “We are pleased that the fast onset of action and mealtime dosing flexibility of
Apidra® will now be available to children 4 years and older.”
Apidra® has a rapid onset and short duration of action and should normally be used in
combination with a longer-acting or basal insulin. Apidra® can also be used in insulin infusion
pump therapy for blood sugar control.
About the Study
The approval of Apidra® for pediatric use is based upon a 26-week, phase III, open-label, active
control study of Apidra® in comparison with insulin lispro in 572 children and adolescents (4 –
17 years of age) with type 1 diabetes. Study patients received insulin glulisine or lispro 0-
15 minutes premeal. These patients received concomitant treatment with insulin glargine once
daily or NPH twice daily as basal insulin. The majority of the patients received insulin glargine as
part of their basal-prandial regimen (69.7% and 72% in the Apidra® and insulin lispro treated
groups, respectively).
The study compared the efficacy of Apidra®
to insulin lispro in terms of change in glycohemoglobin
(HBA1c), which is the amount of sugar bound to hemoglobin in the blood. The change in HBA1c
from baseline to endpoint for Apidra® and insulin lispro were similar. The mean HBA1c change in
the Apidra® population was +0.10% (± 0.08) and +0.16% (± 0.07) in the lispro group. The
difference between the two treatments for this measure was -0.06%, or almost zero, with a 95%
confidence interval of (-0.24; 0.12). HbA1c at baseline was 8.20% (± 1.05) in the glulisine group
and 8.17% (± 1.02) in the lispro group; HbA1c at endpoint was 8.31% (± 1.37) in the glulisine group
and 8.37% (± 1.32) in the lispro group. Postprandial glycemic control, as assessed by the selfmonitored
blood glucose values and blood glucose excursions, was similar in both treatment
groups at endpoint.
No noteworthy differences existed between treatment groups in the number of study patients
reporting hypoglycemia, which is the most common adverse reaction of insulin therapy. This
included hypoglycemia reported as a serious adverse reaction, which occurred in 7.2 percent of
study patients in the glulisine group and 8.1 percent of those in the lispro group.
About 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 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. In
the United States, type 1 diabetes is the most common type of diabetes in children, with
approximately 176,500 people under 20 years of age affected by the disease. Approximately one
out of every 400 to 600 American children and adolescents has type 1 diabetes.
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, adolescents and
children with diabetes. 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 the logical partner to LANTUS® once prandial insulin is
required.
About LANTUS® (insulin glargine [rDNA origin])
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
hyperglycemia and for adult and pediatric patients (6 years and older) with type 1 diabetes
mellitus. LANTUS® demonstrates a peakless and sustained concentration/time profile over
24 hours thus reducing the risk of hypoglycemia and allowing a constant and high efficacy over
24h with one single daily injection. LANTUS® is the number one prescribed insulin worldwide.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).
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