From: Mark_in_MO [#1]
19 Apr 11:49
To: ALL
Well,, it looks like there has been another bump in the road to getting the Byetta LAR product out to the public. Apparently the FDA is concerned that the LAR version of Byetta (NOT the 2X daily version) may have the same potential risk for cancer as Victoza, and thus would probably have the same black box warning as Victoza currently has.
The attached link has all the information:
http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9192&catid=1&Itemid=17
I do not know if this will further significantly delay the release, since there has been no actual indication of a link to cancer, just a concern that it may have the same issue as Victoza. Guess we continue to wait and see what comes down the road.
FYI - Once again, thanks go to "Mr. T" for the heads up on this article.
From: Mr. T (MR_T) [#3]
19 Jun 10:27
To: Mark_in_MO [#1] 19 Jun 12:04
Read the following on Byetta LAR called Bydureon:
"Amylin Pharmaceuticals and its partner Alkermes are awaiting a food and Drug Adminstration decision on the one weekly diabetes treatement Bydureon."
"Bydureon is expected to be a direct competitor to Vicatoza, and the FDA is set to make a decision on the drug by Oct. 22. Bydureon is a long-lasting version of the twice-daily injection Byetta, which is made by Amylin and Eli Lilly"
Not much but some more information on the long awaited release.
From: Mark_in_MO [#5]
19 Jun 12:10
To: Mr. T (MR_T) [#3] 19 Jun 12:44
Finally - a specific decision date. i cannot count the number fo times that the FDA has decided that "additional studies are required" when Amylin has applied for approval. I just hope this results in good news and the FDA approves the Byetta LAR (Bydureon). I think Bydureon will provide significantly greater competition for Victoza, since the Bydureon clinical trials showed that the LAR version of Byetta resulted in even better BG control, more weight loss, less side effects like nausea, and you only have to take a shot "once a week" !
However, I will not be holding my breath until they finally make a decision.
Thanks Mr. T for the update.From: Mr. T (MR_T) [#7]
27 Jun 11:17
To: ALL
Here is another article but sounds similar to other post
http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9498&catid=1&Itemid=17
From: Mark_in_MO [#9]
16 Aug 18:36
To: ALL
Well, once again Mr. T has come through with the latest information on the LAR Byetta (actually named Bydureon) which is basically Byetta that will require a once a week shot.
Per the Diabetes In Control website, the following information was posted:
HEADLINE: Lilly/Amylin amassing significant pre-launch stock of Bydureon, the once-a-week form of Byetta
TEXT: Lilly/Amylin amassing significant pre-launch stock of Bydureon, the once-a-week form of Byetta. October 22nd, 2010 is the likely date Bydureon will be ready to launch. Byetta has only lost 7.7% market share to Victoza.
LINK: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9693&catid=1&Itemid=8
Thanks again to Mr. T for his up-to-date information.
From: Geri in Co:Byetta(3-06) (GERI) [#11]
17 Aug 18:26
To: Mark_in_MO [#9] 18 Aug 14:30
From: Mark_in_MO [#13]
18 Aug 14:31
To: Geri in Co:Byetta(3-06) (GERI) [#11] 19 Aug 10:36
Maybe, but probably not right away. I have to switch insurance next year and may need to wait to switch until I am on the new insurance.
Guess I will have to wait and see.