Special Newsflash: Exenatide Once Weekly -- FDA Update

Last Friday, the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON (exenatide for extended-release injectable suspension).

In the complete response letter there are no requests for new pre-clinical or clinical trials.  Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility.  All of those observations have been addressed.

According to information we received on a conference call this morning with Daniel M. Bradbury, president and CEO, and Orville G. Kolterman, M.D., senior vice president of research and development at Amylin, this is a significant step forward in their ability to bring this important therapy to patients. They now feel that they have a clear path forward and will be working diligently to submit their response to the FDA in the next few weeks.

For those of you who may not know, a complete response letter from the FDA means they are not requesting any new data or studies nor are they requesting new analysis of old data. This request is for label finalization and manufacturing technical data processes.

Further comments during the call included the fact that the extended version of Exenatide has had better results than the bid version currently available and that the FDA is treating this as a line extension of the bid version and so all data concerning pancreatitis will remain the same. Dr. Kolterman did mention that continuous follow-up on the pancreatitis issue has indicated no new signals as to any changes in the data.

There has long been a Risk Evaluation and Mitigation Strategy (REMS) program for Byetta BID (as there are for most newer medications) and there is no expectation that a whole new program will have to be built for the extended version.

In speaking of risk, Mr. Bradbury indicated that the FDA did not ask for any calcitonin data nor are they asking for any new studies. This means that the risk of increased thyroid cancer that earned Victoza(liraglutide), Novo’s new once daily GLP-1 agonist, a black box warning will not likely be seen on Bydureon.

There seems to be some indication that the FDA will approve the extended release version for first line or monotherapy use but Amylin representatives would not confirm or deny that.

In closing, Mr. Bradbury indicated that they feel that there is no need to meet with the FDA prior to the submission of their response, and that they anticipate submitting this response in the next few weeks, and mentioned that once the FDA approves Bydureon for sale it will be about 6-8 weeks till it will be available for use.

For more information, please go to www.byetta.com.