BRIDGEWATER, NJ (April 19, 2004) – The U.S. Food & Drug Administration has approved Apidra, a rapid-acting insulin analogue, for adult patients, Aventis announced. Apidra is a recombinant DNA human insulin analogue that, according to Aventis, has a more rapid onset and a shorter duration of action than regular human insulin after subcutaneous administration.
Frank L. Douglas, executive vice president for drug innovation & approval at Aventis, termed Apidra “a strong addition to the Aventis portfolio of diabetes treatments,” saying that it is similar in action to the insulin made by the body.
Apidra is designed for the treatment of type 1 and type 2 diabetes, to cover mealtime blood sugar spikes, the company said.
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 oftheir 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 inblood glucose levels that happen immediately after eating, according to Aventis.
In the U.S., more than 18 million people have diabetes, including an estimated 5 million who remain undiagnosed.
Apidra was submitted for registration in the European Union and the U.S.in June 2003. It has been studied in clinical trials in adult patients with type 1and type 2 diabetes, Aventis said. It is designed to be injected within 15 minutes before ameal or within 20 minutes after starting a meal. It is intended to be givenby subcutaneous injection, or by continuous subcutaneous pump infusion, the company said.