Amylin and Lilly to re-file Bydureon with US FDA sooner than expected with new tQT data
Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) have announced results from a thorough QT (tQT) study that assessed the potential of their type 2 diabetes drug candidate Bydureon (exenatide extended release) to increase the QT interval across a wide range of plasma concentrations.
The study was conducted to satisfy a requirement by the US Food and Drug Administration in support of the New Drug Application for Bydureon which the agency failed to approve last year on cardiac safety concerns (The Pharma Letter October 20, 2010) and then, in a second complete response letter relating to the NDA, called for additional data. . The companies now plan to submit results of the tQT study to the FDA in the third quarter of 2011 as part of their reply to the complete response letter for the Bydureon, which is sooner than the end-2011 date previously expected.
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