Press Release: FDA Approves New Route of Administration for Sanofi-Aventis's Rapid-Acting Apidra
FDA Approves New Route of Administration for Sanofi-Aventis's Rapid-Acting Apidra BRIDGEWATER, N.J., June 15 -- Sanofi-aventis announced today that following a review of a supplemental New Drug Application (sNDA), the U.S. Food and Drug Administration (FDA) has approved the rapid- acting insulin ApidraÂ® (insulin glulisine [rDNA origin] injection) for intravenous administration under proper medical supervision in a clinical setting for glycemic control in adult patients with type 1 and type 2 diabetes. The approval provides an additional treatment option for the many hospitalized diabetes patients who may benefit from intravenous insulin therapy in a clinical setting. The FDA based its decision on results from a randomized, open-label, two- way crossover study of 16 healthy male subjects who received an intravenous infusion of Apidra or regular human insulin with saline diluent at a rate of 0.8 IU/kg/min for two hours. Infusion of the same dose of Apidra or regular human insulin produced equivalent glucose disposal at steady state. "Many of the patients I treat in the inpatient setting have diabetes and require intravenous insulin," said Christopher A Newton, MD, Assistant Professor of Medicine, Division of Endocrinology, Department of Internal Medicine, Brody School of Medicine, East Carolina University. "The new indication for Apidra is an important development, as it gives clinicians a new option to help achieve and maintain blood glucose control in these patients in this setting." Apidra was approved in April of 2004 for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. In addition to intravenous use, when treating type 1 or type 2 diabetes patients with hyperglycemia in a clinical setting, Apidra can be administered subcutaneously in vial form, insulin pen, or external insulin infusion pump. OptiClik is the reusable insulin delivery device (insulin pen) for use with a 3-mL Apidra cartridge (U-100). Sanofi-aventis' insulin portfolio also includes once-daily, 24-hour, long- acting LantusÂ® (insulin glargine [rDNA origin] injection), the number one prescribed insulin in the world. About Apidra Apidra is a rapid-acting insulin that offers patients mealtime dosing flexibility-it can be taken within 15 minutes before or within 20 minutes after starting a meal. Apidra is also flexible for use in diabetes patients with diverse body types from lean to obese. Nearly 9 out of 10 people with newly diagnosed type 2 diabetes are overweight, and for patients that require insulin therapy, this presents an additional challenge, as being overweight can affect the speed at which insulin is absorbed by the body. In clinical studies, Apidra was found to maintain its rapid onset of action and absorption when it was given to subjects with lean to obese body types. About Lantus Lantus, the number one prescribed insulin in the world, is the only 24- hour insulin approved exclusively for use once a day. Insulins have what is called a "peak of action" which refers to the time at which insulin reaches its maximum effect in the body. With Lantus, 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 Apidra is for adults with type 1 or type 2 diabetes for the control of high blood sugar. Apidra should normally be used with a longer-acting insulin. Do not use Apidra during a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine. OptiClik is a reusable insulin delivery device (insulin pen) for use with a 3-mL Apidra cartridge (U-100). Needles and the OptiClik pen must not be shared. Apidra differs from regular human insulin by its rapid onset and shorter duration of action. When used as a mealtime insulin, Apidra should be given within 15 minutes before or within 20 minutes after starting a meal. Due to the short duration of action of Apidra, 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. Please visit www.Apidra.com for full prescribing information. Important Safety Information for Lantus Prescription Lantus 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 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 if you are allergic to insulin. Lantus 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. The most common side effect of insulin, including Lantus, 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. Please visit www.Lantus.com for full prescribing information. About sanofi-aventis Sanofi-aventis is one of the world leaders in the pharmaceutical industry, 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 - News). 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, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.