INDIANAPOLIS (dpa-AFX) - Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes Inc. (ALKS) announced results from a thorough QT or tQT study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations.
The company said that the study was conducted to satisfy a requirement by the U.S. Food and Drug Administration in support of the New Drug Application for Bydureon, an investigational medication for type 2 diabetes. Bydureon is the proposed brand name for exenatide extended-release for injectable suspension. Bydureon received marketing authorization in the European Union in June 2011.
The companies said that they 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 NDA.
Using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint, demonstrating that exenatide at and above therapeutic levels did not prolong the corrected QT interval in healthy individuals. Further, the study found no relationship between corrected QT interval and plasma exenatide concentrations, the company said.
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