Amylin, Eli Lilly and Alkermes have received an FDA complete response letter for Bydureon, but the companies note in an announcement that there are no requests for new pre-clinical or clinical trials. The agency's prime concerns relate to the product labeling with accompanying risk evaluation and mitigation strategy and clarification of existing manufacturing processes. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks," says Orville Kolterman, senior vice president of research and development at Amylin. The companies add that the issues found at Amylin's manufacturing plant in December have been addressed.
Bydureon (also known as Byetta LAR) is the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient's bloodstream, Bydureon can be administered once a week rather than requiring twice-daily injections. All three companies have a lot riding on Bydureon--a potential blockbuster that could rack up billions in annual sales.
- here's Amylin's release