Lilly, Alkermes and Amylin report that the latest safety data ordered by the FDA on Bydureon show that the drug does not cause heart problems even at high doses. Specifically, Bydureon in the latest tests caused no QT prolongation in the healthy test subjects. This is good news for Bydureon's chances at approval in the US. It was approved already in Europe last month.
Bydureon is a once-per week treatment for the control of type II diabetes. Analysts have previously estimated that it could reach peak sales of $2.4 billion by 2016. The companies will be submitting the new data to the FDA by September. Amylin and Alkermes, in particular have much to gain when the drug finally is approved for use in the US. See Xconomy.
Posted by Bruce Lehr July 8th 2011.