Lilly withdraws European Applcation for Arxxant
Lilly last week withdrew its application with the European Medicines Agency (EMEA) for Arxxant (ruboxistaurin)
PharmaLive: Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant
The given reason was that they could not respond to the request for the additional information in the required amount of time. Lilly lost an appeal just a few days earlier than this where the FDA upheld thier decision to require additional clinical trials before it would be considered for approval. Lilly said it would take an additional 3-5 years to complete those studies.
My wife is diabetic and has already had some eye problems related to her disease and so I have been following this drug with a personal interest. It will be interesting to see what Lilly will do. Somewhere right now someone is plugging numbers into a spreadsheet to see if it is worthwhile for Lilly to make an additional investment in this drug. Since I have a personal interest in this, I certainly hope so.
Other Resources
Eli Lilly withdraws its marketing authorisation application for ARXXANT (from EMEA website)
FDA rejects Eli Lilly appeal - Pharmaceutical Business Review
Lilly’s Arxxant Hits FDA Snag - Forbes.com (from back in Aug 2006)
Approvable Letter Issued By FDA For Arxxant(R) (ruboxistaurin Mesylate) For Diabetic Retinopathy
Arxxant - Yahoo! Search Results
Arxxant - Google Search
Google Blog Search: Arxxant
Technorati Tags: Arxxant, ruboxistaurin
Related Posts:
Bookmark it with:
| 
del.icio.us
| 
Digg it
| 
Furl
| 
Simpy
| 
Spurl
| 
My Yahoo!
|
