European Commission Approved APIDRA® for Treatment of ... - Sanofi

European Commission Approved APIDRA ®
for Treatment of Children & Adolescents
with Diabetes
Apidra ® (insulin glulisine [rDNA origin] injection),
labelled for use shortly before or soon after meals,
now provides an effective treatment option for adults,
adolescents & children (6 years and older) with diabetes
Paris, France - July 24, 2008 - Sanofi-aventis announced today that the European Commission
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 mellitus.
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 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 pediatric 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 pediatric patients and their healthcare providers with new treatment options,”
said Riccardo Perfetti, MD PhD, Senior Medical Director, Diabetes-Metabolism Franchise, sanofiaventis.
“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
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.
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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 Humalog ® , in more than 572 children and adolescents
(4 years and older) with type 1 diabetes.
Study patients received APIDRA ® or Humalog ® 0-15 minutes premeal. These patients received
concomitant treatment with LANTUS ® once daily or NPH twice daily as basal insulin. The majority of
the patients received Lantus ® as part of their basal-prandial regimen (69.7% and 72% in the APIDRA ®
and Humalog ® treated groups, respectively).
The study compared the efficacy of APIDRA ® to Humalog ® in terms of change in glycohemoglobin
(HbA 1c), which is the amount of sugar bound to hemoglobin in the blood. The change in HbA 1c from
baseline to endpoint for APIDRA ® and Humalog ® were similar. The mean HbA 1C change in the
APIDRA ® population was +0.10% (± 0.08) and +0.16% (± 0.07) in the Humalog ® 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). Postprandial glycemic control, as assessed by the self-monitored blood glucose
values and blood glucose excursions, was similar in both treatment groups at endpoint.
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 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
relatively 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 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 SoloSTAR ®
SoloSTAR ® is a new, easy-to-use disposable pen for administration of LANTUS ® and APIDRA ® .
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 ®
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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.
The Chicago Athenaeum Museum of Architecture and Design awarded a 2007 GOOD DESIGN
Award for the new SoloSTAR ® disposable insulin injection pen for people with type 1 and type 2
diabetes. The Museum’s historic GOOD DESIGN program was founded in Chicago in 1950 by Edgar J.
Kaufmann, Jr. with the participation of some of America’s most important designers. Every year the jury
meets in New York and select products and graphics worthy of the GOOD DESIGN Award for design
distinction. GOOD DESIGN remains the oldest and most important Awards program 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).
Global Media Contact:
Anna Radjanova, MD
Tel: + 33 (0)6 07 28 61 63
E-mail: anna.radjanova@sanofi-aventis.com
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