FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

BRIDGEWATER, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra(R) (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes mellitus.

The approval of Apidra(R) for pediatric use is based upon FDA review of a 26-week, phase III, open-label, active control study of Apidra(R) 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(R) will now be available to children 4 years and older."

Apidra(R) has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. Apidra(R) can also be used in insulin infusion pump therapy for blood sugar control.

About the Study

The approval of Apidra(R) for pediatric use is based upon a 26-week, phase III, open-label, active control study of Apidra(R) 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(R) and insulin lispro treated groups, respectively).

The study compared the efficacy of Apidra(R) 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(R) and insulin lispro were similar. The mean HBA1c change in the Apidra(R) population was +0.10% (+ or - 0.08) and +0.16% (+ or - 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% (+ or - 1.05) in the glulisine group and 8.17% (+ or - 1.02) in the lispro group, HbA1c at endpoint was 8.31% (+ or - 1.37) in the glulisine group and 8.37% (+ or - 1.32) in the lispro group. Postprandial glycemic control, as assessed by the self-monitored 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(R)

Apidra(R) is a rapid-acting insulin that can be administered using an insulin infusion pump, vial and syringe, the OptiClik(R) reusable insulin pen, or intravenously under proper medical supervision in a clinical setting. Apidra(R) works fast and offers flexible insulin dosing to help manage mealtime blood sugar levels. It should be administered within 15 minutes before or within 20 minutes after the start of a meal. Along with exercise, a basal insulin, and a proper meal plan, Apidra(R) is proven to help reduce A1C levels in adults and children (4 years and older) with type 1 diabetes and adults with type 2 diabetes.

Apidra(R) is from the maker of Lantus(R) (insulin glargine [rDNA origin] injection), the number one prescribed insulin.*

About Lantus(R)

Lantus(R) is indicated for the treatment of adult and pediatric patients 6 years and older with type 1 diabetes, or adult patients with type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia. Lantus(R) is the only 24-hour insulin approved exclusively for use once a day. Most insulins have a "peak of action," which refers to the time at which insulin reaches its maximum effect in the body. With Lantus(R), the insulin is released into the bloodstream at a relatively constant rate throughout the day and night; therefore it has no pronounced peak.

IMPORTANT SAFETY INFORMATION FOR APIDRA(R)

Apidra(R) is for adults and children (4 years and older) with type 1 diabetes and adults with type 2 diabetes for the control of high blood sugar. Apidra(R) should normally be used with a longer-acting insulin. Do not use Apidra(R) during a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine.

Apidra(R) differs from regular human insulin by its rapid onset and shorter duration of action. When used as a mealtime insulin, Apidra(R) should be given within 15 minutes before or within 20 minutes after starting a meal. Due to the short duration of action of Apidra(R), patients also require a longer-acting insulin or insulin infusion pump therapy. Any change of insulin should be made cautiously and only under medical supervision. Tell your doctor about all other medicines and supplements you are taking. Glucose monitoring is recommended for all patients with diabetes.

Possible side effects may include low blood sugar; injection site reactions, such as changes in fat tissue at the injection site; and allergic reactions, such as itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to insulin, including anaphylactic reactions.

When used in a pump, do not mix Apidra(R) with any other insulin or liquid. If the pump or infusion set does not work right, you may not receive the right amount of insulin. Hypoglycemia, hyperglycemia, or ketosis can happen. Problems should be identified and corrected as quickly as possible.

For full prescribing information, please visit www.Apidra.com.

IMPORTANT SAFETY INFORMATION FOR LANTUS(R)

Prescription Lantus(R) is for adults with type 2 diabetes or adults and children (6 years and older) with type 1 diabetes who require long-acting insulin for the control of high blood sugar.

DO NOT DILUTE OR MIX LANTUS(R) WITH ANY OTHER INSULIN OR SOLUTION. It will not work as intended, and you may lose blood sugar control, which could be serious. Do not change your insulin without talking with your doctor. The syringe must not contain any other medication or residue. You should not use Lantus(R) if you are allergic to insulin. Lantus(R) is a long-acting insulin you inject just once a day, at the same time each day. You must test your blood sugar levels while using an insulin such as Lantus(R).

The most common side effect of insulin, including Lantus(R), is hypoglycemia, which may be serious. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works.

For full prescribing information, please visit www.Lantus.com.

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). For more information, please visit www.sanofi-aventis.us or www.sanofi-aventis.com [1].

* Based on TRx data from IMS Health, National Prescription AuditTM (Next Generation Prescription Methodology). Time period: May 2003 to April 2008.

SOURCE Sanofi-aventis