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news.Eli Lilly, Amylin Pharmaceuticals and Alkermes have submitted reply to the US Food and Drug Administration's (FDA) complete response letter (CRL) for Bydureon's (exenatide extended-release for injectable suspension) new drug application (NDA), which was originally filed in May 2009.
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The CRL was issued by the FDA in October 2010 for the NDA of the experimental type 2 diabetes drug Bydureon.
In their reply, the companies have provided updated safety information from ongoing or completed studies since the last submission.
The companies have also included results of QT (tQT) study which demonstrated 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.
Amylin Research and Development senior vice president Christian Weyer said they worked to complete the requested tQT study and consulted with the FDA throughout the process.
"We are confident that the study results and our detailed submission have addressed the requirements outlined by the FDA, and we remain committed to making Bydureon available to patients in the US as soon as possible," Weyer said.