BRIDGEWATER, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra(R) SoloSTAR(R) (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra(R), which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.
The approval of Apidra(R) SoloSTAR(R) follows the approval and launch of Lantus(R) SoloSTAR(R) (insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus(R) and Apidra(R) to help manage their blood sugar will now have two pen delivery devices to make administration of their insulins convenient. Basal-prandial insulin regimens that combine once-daily Lantus(R) as a basal insulin analog with rapid-acting Apidra(R) at mealtime can closely mimic normal physiologic insulin secretion.
"Patients with diabetes have to contend with the challenges of carbohydrate counting, regular blood sugar monitoring and careful administration of their insulin," said Angela Moskow, Vice President, Metabolism Marketing, sanofi-aventis, U.S. "Apidra(R) SoloSTAR(R) represents another innovation introduced by sanofi-aventis that offers patients a convenient option for administering their Apidra(R)."
The Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) pens are the result of over four years of intensive development, and were designed in dialogue with patients, nurses and doctors to meet their needs and the high standards of the industry.
Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very different types of insulins (rapid-acting vs. long-acting). The differentiation of the Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) was shown in a specific comparative study. Nevertheless, before using Apidra(R) SoloSTAR(R) or Lantus(R) SoloSTAR(R), patients should carefully examine the labeling on the pen, to ensure they are using the correct one. Apidra(R) SoloSTAR(R) operates with a low injection force and two studies found that this delivery device required less injection force than the Novo Nordisk FlexPen and the Eli Lilly Humulin/Humalog pen.
Apidra(R) SoloSTAR(R) is expected to be available in pharmacies this year.
For more information on Apidra(R) or Apidra(R) SoloSTAR(R) please visit www.Apidra.com.
For more information on Lantus(R) or Lantus(R) SoloSTAR(R) please visit www.Lantus.com.
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. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, approximately 40 percent of those diagnosed are not achieving the blood sugar control target of A1C <7 percent recommended by the ADA. The A1C test measures average blood glucose levels over the past two- to three-month period.
About Apidra(R) and Apidra(R) SoloSTAR(R)
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) can be administered using an insulin pump, vial and syringe, the OptiClik(R) reusable insulin delivery device, the Apidra(R) SoloSTAR(R) prefilled disposable insulin pen or intravenously under proper medical supervision in a clinical setting.
Apidra(R) SoloSTAR(R) is a prefilled, disposable insulin pen that is easy-to-use. Apidra(R) SoloSTAR(R) eliminates the need for the patient to change cartridges.
Apidra(R) SoloSTAR(R) should be kept in cool storage (36 degrees F - 46 degrees F [2 degrees C - 8 degrees C]) until first use. Once in use, it can be kept at room temperature, as long as it remains below 77 degrees F [25 degrees C], away from direct heat and light, and can be used for up to 28 days.
Apidra(R) is from the maker of Lantus(R), the number one prescribed insulin.*
About Lantus(R) and Lantus(R) SoloSTAR(R)
Lantus(R) is the only 24-hour insulin approved exclusively for use once a day. 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.
Lantus(R) SoloSTAR(R) is easy-to-use and requires a few straightforward steps to use it properly. Lantus(R) SoloSTAR(R) eliminates the need for the patient to change cartridges.
Lantus(R) SoloSTAR(R) should be kept in cool storage (36 degrees F - 46 degrees F [2 degrees C - 8 degrees C]) until first use. Once in use, it should be kept at room temperature, as long as it remains below 86 degrees F [30 degrees C], away from direct heat or light, and can be used for up to 28 days.
IMPORTANT SAFETY INFORMATION FOR APIDRA(R)
Prescription Apidra(R) is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra(R) should normally be used with a longer-acting insulin. Apidra(R) may also be infused subcutaneously by external insulin infusion pumps. Do not use Apidra(R) during a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine.
OptiClik(R) is a reusable insulin delivery device for use with a 3-mL Apidra(R) cartridge (U-100). Needles, OptiClik(R) and cartridge systems must not be shared.
Apidra(R) SoloSTAR(R) is a prefilled disposable insulin pen. Needles and the
SoloSTAR(R) pen must not be shared.
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.
OptiClik(R) is a reusable insulin delivery device for use with a 3-mL Lantus(R) cartridge (U-100). Needles, OptiClik(R) and cartridge systems must not be shared.
Lantus(R) SoloSTAR(R) is a prefilled disposable insulin pen. Needles and the
SoloSTAR(R) pen must not be shared.
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 long-acting insulin you inject just once a day, at the same time each day. You must test your blood sugar levels while using 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) .
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
U.S. Contact:
Carrie Melia
Carrie.melia@sanofi-aventis.com
908-981-6486
US.GLU.08.06.015
(C) 2009 sanofi-aventis U.S. LLC
* Based on TRx data from IMS Health, National Prescription AuditTM (Next Generation Prescription Methodology). Time period: May 2003 to September 2008.
Source: sanofi-aventis
CONTACT: U.S. - Carrie Melia, sanofi-aventis,
Carrie.melia@sanofi-aventis.com, +1-908-981-6486