I had hoped that this week’s Clinical Mastery edition would have included information from the Duration Trials for the once weekly form of exenatide, Bydureon. Many of us had been anticipating approval of this revolutionary treatment for diabetes, and were anxious to have this new treatment option for our patients.
It seems however that the FDA decided to change the rules in the middle of the game. After accepting all of the data in March, on Monday they informed Amylin that they would have to do a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon.
This will probably push the release date back to at least mid 2012 or later.
This delay in approval means that for many of our patients Intensified Insulin Therapy will be a prominent solution for their diabetes and so this week we are focusing again on the proper way to dose insulin as well as how to write prescriptions to avoid errors and our Homerun slides help deliver information on the challenges we face when we work with older patients.