It's playoff season in baseball and as every fan knows good pitching stops good hitting. In keeping with the theme, the FDA threw Amylin, Alkermes and Lilly a nasty curveball in turning down their application for the once-weekly diabetes drug, Bydureon.
In the agency's complete response letter, they've asked for a new study on QT Rhythm that would assess whether the drug is responsible for irregular heartbeat in trial patients. The three companies, clearly caught by surprise, indicated the issues were not "garden variety". Unlike the previous FDA letter, which focused on manufacturing risk mitigation, this letter raises questions about safety and effectiveness. Who says there's no predictability and consistency with the FDA? The setback may be inspired by events that occurred with Avandia's approval and subsequent removal/restriction due to increased heart risks in patients receiving the drug.
All three companies were counting on the revenue from Bydureon to augment their flagging sales column. Now, with the latest FDA request, they don't believe they will be able to file their data for re-submission until the end of 2011. Both Amylin and Alkermes are expected to suffer from the delay. Amylin in particular was depending heavily on the Bydureon revenue and its stock can be expected to dive when the markets open. Even since the March decision, they've restructured and cut staff - now there may need to be another round. See Xconomy.
Posted by Bruce Lehr October 19th 2010.