"While I'll plant my flag in the camp expecting an approval, I'd caution investors not to go all-in here. It's not unprecedented for minor issues to trip up companies multiple times. Worse yet, we've seen the FDA to come up with new issues even after having another six months to review the drug."
I wrote that yesterday in passing, knowing it was a possibility, but not really expecting it to become a reality. Turns out, my warning was more valid than I thought. Amylin Pharmaceuticals
The first request is for the data from the Duration-5 trial. That should be simple enough to provide, since the trial is already complete. Duration-5 is essentially an identical design to the Duration-1 trial, which was used in the marketing application -- it compared Byetta to Bydureon -- but Duration-5 used Bydureon produced at commercial scale while the first trial used drug produced in smaller batches.
The second request will take more time to accomplish. The FDA now wants a thorough QT study which measures the effect of active ingredient in Byetta and Bydureon on heart rhythms.
It appears we can blame this one on GlaxoSmithKline's
Amylin is guiding for finishing the study by the end of next year, but it could potentially be done earlier depending on exactly what the FDA wants the study to look like. Typically these are single-dose studies, but Bydureon is an extended-release formulation, which may complicate the dosing. Ideally the FDA will let Amylin use Byetta to run the study, since they contain the same active ingredient. That would make things much simpler.
The big winner here is Novo Nordisk
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