FDA wants more Bydureon data

FDA issued a second complete response letter for an NDA from Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) for Bydureon exenatide once weekly that could result in a delay of 18 months or more for the Type II diabetes product candidate. According to Amylin and partners Eli Lilly and Co. (NYSE:LLY) and Alkermes Inc. (NASDAQ:ALKS), FDA requested a thorough QT study with higher exposures of exenatide that would be consistent with those seen in patients with renal impairment to determine if Bydureon could be associated with QT prolongation in these patients. The companies also said FDA requested the submission of data from the DURATION-5 trial, which was not included in the original NDA submission. The companies reported last December that Bydureon met the trial's primary endpoint of significantly reducing HbA1c from baseline to week 24 vs. twice-daily Byetta exenatide.

The partners hope to submit a response by the end of next year pending discussions on the design of the QT study with FDA. The companies said it is likely that the response will be considered a Class 2 resubmission, which requires a six-month review. FDA issued the first complete response letter in March. That letter included requests related to the finalization of product labeling with a REMS and clarification of existing manufacturing processes. ...