Full QT study for once-weekly Bydureon comes out clean, as expected, paving way for NDA resubmission
This article was originally published in Scrip
Executive Summary
Amylin, Lilly and Alkermes have given Wall Street more good news about once-weekly Bydureon, the glucogen-like peptide-1 agonist exenatide in type 2 diabetes, still under review by US regulators. It was not a surprise to many, but Amylin announced that the FDA-required full QT study confirmed that Bydureon, at and above therapeutic levels, did not prolong corrected QT (QTc) interval in healthy volunteers, nor did not it show dose-dependent increase in QTc interval at higher dose levels.