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.
It is not clear whose technology is to "blame," if there is any single factor. However, remember, Alkermes' delivery technology has already received an OK from the FDA in another drug, Vivitrol.
The Street calls the rejection a "debacle," but it views these companies purely as stock ticker symbols. It seems like it would have been worse for the FDA to have approved the drug without thoroughly checking into potential negative effects on the heart. The FDA has been down that road before, and "debacle" would be the nicest thing that could be said about those days.