FDA Delays Decision on Byetta
This morning Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) announced the Food and Drug Administration (FDA) ) is continuing with its review of the regulatory application for use of BYETTA® (exenatide) injection as stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009.
Diabetic Investor does believe this announcement is necessarily a negative and more likely has to do with the FDA being in state of transition. The same reason the panel meeting for Novo Nordisk’s (NYSE:NVO) GLP-1 liraglutide was pushed back one month. As we pointed out last week the FDA is likely to see new leadership with the change in administrations and the agency has slowed their review process as they await new leadership.
According to a joint press release "Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville G. Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "Importantly, we have not received any request for additional studies. We look forward to working closely with the agency as needed throughout the review process."
There was no mention in the release on when the companies would be announcing a possible label change for Byetta, which is also being discussed with the FDA.