ARTICLE | Regulation

Haunted by Byetta

Byetta study ruins Amylin-Lilly timetable for Bydureon in diabetes

October 25, 2010 7:00 AM UTC

Instead of a relatively small QTc study, Amylin Pharmaceuticals Inc. and Eli Lilly and Co. took a different tack - initially with FDA's blessing - that now looks likely to cost the partners at least 18 months of sales of once-weekly Bydureon exenatide, allow a recently approved competitor to gain a strong foothold in the market, and give companies now in Phase III a window to catch up.

In 2006, Amylin, Lilly and FDA agreed on a relatively simple process for confirming Bydureon's QT profile. The partners did a subset analysis of QT in their Phase III trial instead of a dedicated study in healthy volunteers, known as a thorough QT (tQT) study, which is a standard test for new drugs according to a 2005 FDA/ICH guidance...