FDA Accepts Once-Weekly Exenatide for Review

7 July 2009 (Last Updated July 7th, 2009 18:30)

The US Food and Drug Administration has accepted for review a New Drug Application (NDA) for the once-weekly diabetes drug exenatide produced by Amylin Pharmaceuticals, Eli Lilly and Alkermes. Exenatide is an investigational sustained release medication for type 2 diabetes that is adminis

The US Food and Drug Administration has accepted for review a New Drug Application (NDA) for the once-weekly diabetes drug exenatide produced by Amylin Pharmaceuticals, Eli Lilly and Alkermes.

Exenatide is an investigational sustained release medication for type 2 diabetes that is administered once a week subcutaneously by injection.

Exenatide is the active ingredient in Byetta (exenatide) injection, which is available in the US and other countries for people with type 2 diabetes who are unable to achieve good glycaemic control with common oral therapies.

Amylin Pharmaceuticals senior vice-president of research and development Orville G Kolterman said that the acceptance of the NDA submission for exenatide once weekly is an important milestone in the exenatide development programme and in the treatment of type 2 diabetes.

“If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week,” Kolterman said.