The Food and Drug Administration (FDA) announced that following the closure of FDA building due to extreme weather it was granting a five day extension for the review of Amylin Pharmaceuticals Inc and Eli Lilly and Co’s Exenatide Once Weekly New Drug Application. The new drug is part of a collaboration between the companies started in 2002, which includes the currently available twice daily type 2 diabetes drug Byetta.
Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.
Both companies released confirmations of this extension.