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Rapid-Acting Insulin Analogue Apidra Gains FDA Approval

BRIDGEWATER, N.J., April 19 /PRNewswire/ -- Aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Apidra(R) (insulin glulisine [rDNA origin] injection), a rapid-acting insulin analogue, for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. Apidra is a recombinant DNA human insulin analogue that has a more rapid onset and a shorter duration of action than regular human insulin after subcutaneous administration.

"We are pleased the FDA recognizes the important role Apidra can play for people with diabetes," said Frank L. Douglas, Executive Vice President for Drug Innovation and Approval and Member of the Board of Management at Aventis. "Apidra is similar in action to the insulin made by the body, making it an effective insulin therapy. Aventis is now able to offer a full spectrum of diabetes treatment options for optimal management of blood glucose control in diabetes. Apidra is a strong addition to the Aventis portfolio of diabetes treatments."

Apidra is designed for the treatment of type 1 and type 2 diabetes, to cover mealtime blood sugar spikes. In combination with Lantus(R) (insulin glargine [rDNA origin] injection), a 24-hour basal insulin also made by Aventis, Apidra provides a synergistic approach to total glucose control.

Diabetes is a chronic, widespread condition in which the body does not produce, or properly use insulin, the hormone needed to convert glucose (sugar) into energy. People with diabetes may need different types of insulin at certain times of the day and at different stages of the progression of their diabetes to help them manage their blood glucose levels. Rapid-acting insulins can be taken shortly before or after a meal to control the peaks in blood glucose levels that happen immediately after eating.

Controlling blood sugar levels is an important key to fighting the current diabetes epidemic. In the U.S., more than 18 million people have diabetes, including an estimated 5 million who remain undiagnosed. At the same time, approximately 60 percent of those diagnosed are not in control. According to the American Diabetes Association, the optimal control goal for people with diabetes is an A1C level of less than 7 percent. The A1C test measures blood glucose levels over a two- to three-month period. The United Kingdom Prospective Diabetes Study (UKPDS) showed that using insulin in the treatment of type 2 diabetes can -- when combined with oral medications, diet, and exercise -- help people with diabetes achieve and maintain tight glucose control, helping to reduce their risk of blindness, amputation, kidney failure, stroke and heart attack.

About Apidra(R) (insulin glulisine [rDNA origin] injection)
Apidra was submitted for registration in the European Union and the U.S. in June 2003.

Apidra has been studied in clinical trials in adult patients with type 1 and type 2 diabetes. It is designed to be injected within 15 minutes before a meal or within 20 minutes after starting a meal. It is intended to be given by subcutaneous injection, or by continuous subcutaneous pump infusion.

Hypoglycemia is the most common adverse effect of insulin therapy, including Apidra. Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.

About LANTUS(R) (insulin glargine [rDNA origin] injection)
LANTUS(R) (insulin glargine [rDNA origin] injection) 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 of age and older) with type 1 diabetes mellitus. LANTUS(R) demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.

LANTUS(R) must not be diluted or mixed with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner.

The adverse events commonly associated with LANTUS(R) include the following: hypoglycemia, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions. Hypoglycemia is the most common adverse effect of insulins, including LANTUS(R). For additional information, please visit: www.lantus.com.

Source: Aventis

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