FDA rejects diabetes drug that includes Alkermes' delivery tech Read more: FDA rejects diabetes drug that includes Alkermes' delivery tech - FierceDr

The FDA's rejection Tuesday of the diabetes drug Bydureon is being reported as a big loss for all three companies with a stake in the once-a-week therapeutic driven by Alkermes' drug delivery technology. There will be a great deal of chatter today about how Eli Lilly, Amylin and Alkermes are big losers in Bydureon's second thumbs-down by the regulatory agency.The agency is asking the companies to come up with a new study looking at whether the drug could be connected to irregular heartbeats in patients. It's asking for a thorough study on what is called the QT interval, which is used to predict possible disruptions in rhythm. The FDA is worried that patients with impaired kidney functions, in combination with the Bydureon, could be candidates for heart attacks. So, it's back to the drawing board and the drug will likely not be back before the FDA until late 2011 or early 2012.