FDA accepts exenatide once weekly diabetes insulin for review

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The FDA has accepted the new drug application (NDA) for exenatide once weekly from Amylin Pharmaceuticals, Eli Lilly and Alkermes.

Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week, according to the companies.

Exenatide is the active ingredient in Byetta (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies, the San Diego-based Amylin, the Indianapolis-based Lilly and the Cambridge, Mass.-based Alkermes. Byetta can be used an add-on therapy for people currently using metformin, a sulfonylurea or a thiazolidinedione.