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FDA Approves Flexible Administration Schedule For Lantus (Insulin Glargine [rDNA Origin] Injection)

BRIDGEWATER, NJ -- May 8, 2003 -- Aventis today announced that its basal insulin, Lantus®, has been approved by the U.S. Food and Drug Administration for flexible administration at any time of day.

Lantus is the first and only basal insulin analog that provides 24-hour glucose lowering activity with just one injection. This new approval in the dosing schedule for Lantus from once daily at bedtime to flexible daily dosing means patients using Lantus may have more options in managing their diabetes.

The long lasting basal insulin should be administered once daily at any time, but at the same time each day. "Uncontrolled diabetes is reaching epidemic levels putting millions of people around the world at risk for devastating complications including blindness, heart disease, amputation and kidney damage. It is through medical advances that offer new treatment and dosing options, that patients with diabetes will gain better control of their disease," says Francois Nader, MD, Senior Vice President, Medical Affairs, Aventis Pharmaceuticals, North America. "Aventis is committed to meeting the needs of patients with diabetes by continuing our clinical development program for Lantus and other promising new products in our pipeline."

Basal insulin therapy can effectively help patients with diabetes achieve tight blood sugar control, defined by the American Diabetes Association (ADA) as an A1C<7.0 percent and by the International Diabetes Federation (IDF) as an A1C<6.5 percent; however, less than half of the more than 11 million Americans diagnosed with diabetes are meeting these blood sugar goals. Worldwide, less than 20 percent of the people with diabetes have good metabolic control.

Lantus demonstrates a slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours. It is unique in that it has no pronounced peak. Lantus also has a consistent delivery of insulin and similar absorption and consistency of action regardless of injection site.

About Lantus (insulin glargine [rDNA origin] injection)
Lantus is indicated for once-daily subcutaneous administration for 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. Studies have shown that Lantus provides a relatively constant concentration/time profile over 24 hours with just one shot a day.

LANTUS 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 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. For full prescribing information, please visit: http://www.lantus.com.


Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com. Also available at this U.S. Web site are copies of this release or any recent release.


SOURCE: Aventis

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