|Amylin, Eli Lilly And Alkermes Reply To Complete Response Letter Issued By U.S. Food and Drug Administration (FDA)|
|By Staff and Wire Reports|
|Thursday, 28 July 2011 19:30|
Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type II diabetes.
The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class II resubmission requiring up to six months for review.
The reply submission includes results from the recently completed thorough QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals as defined by the FDA’s published guidance. The reply also contains results from the DURATION-5 study, which compared the commercial formulation of BYDUREON to BYETTA (exenatide) injection.
Additionally, it includes an update of safety information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario. BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational medication for type II diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose.
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