NDA Accepted for Once-Weekly Injectable Diabetes Drug

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The FDA has accepted a New Drug Application (NDA) for exenatide once weekly. The drug is an investigational sustained-release medication for type 2 diabetes that is injected subcutaneously only once a week.

Exenatide is the active ingredient in Byetta injection, which is available in the United States and other countries for patients with type 2 diabetes who are unable to achieve adequate glycemic control with oral drugs. Exenatide once weekly is being developed by Amylin Pharmaceuticals, of San Diego; Eli Lilly and Company, of Indianapolis; and Alkermes, Inc., of Cambridge, Mass.

“Acceptance of the NDA submission for exenatide once weekly is an important milestone both in the exenatide development program and in the treatment of type 2 diabetes,” said Orville G. Kolterman, MD, Amylin's Senior Vice President of Research and Development.

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

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