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Diabetes
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my personal edition > diabetes > news
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DGNews
FDA Approves OptiClik(TM), New Insulin Pen System from Aventis
BRIDGEWATER, N.J. -- August 12, 2004 -- Aventis announced today that the U.S. Food and Drug Administration (FDA) has approved OptiClik(TM), a new reusable pen for injecting 24-hour Lantus(R) (insulin glargine [rDNA origin] injection) for people with type 1 and type 2 diabetes.
"The OptiClik(TM) pen will provide people with diabetes with a new and easy-to-use delivery option, one that will complement Lantus(R), the first and only 24-hour basal insulin analog," said Kim Carroll, Vice President, Diabetes at Aventis. "The approval of OptiClik(TM) provides more patient choice and expands the Aventis portfolio of innovative diabetes offerings."
"With the approval of OptiClik(TM), Aventis furthers its goal of offering people with diabetes an integrated system of insulin products and choice of delivery devices to achieve precision dosing and meet their needs for blood glucose control," adds John Harrington, Vice President Metabolism Business Unit at Aventis.
Controlling blood sugar levels is an important key to fighting the current problem of uncontrolled diabetes. 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 goal for people with diabetes is a haemoglobin A1c level of less than 7 percent. The A1c test measures blood glucose levels over a two- to 3-month period. The United Kingdom Prospective Diabetes Study and Diabetes Control and Complications Trial 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 Lantus (insulin glargine [rDNA origin] injection)
Lantus 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 hyperglycaemia and for adult and pediatric patients (6 years of age and older) with type 1 diabetes mellitus. It demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.
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: hypoglycaemia, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions. Hypoglycaemia is the most common adverse effect of insulins, including Lantus(R). For additional information, please visit: http://www.Lantus.com.
In April 2004, the U.S. Food and Drug Administration approved APIDRA(R), a rapid-acting insulin analogue, for the treatment of adult patients with diabetes mellitus for the control of hyperglycaemia. In combination with Lantus(R), APIDRA(R) provides a synergistic approach to total glucose control. APIDRA(R) was submitted for registration in the European Union in June 2003.
SOURCE: Aventis
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