Posted by PeterJ on July 29, 2006, at 11:12:20
In reply to EMEA - refusal for Valdoxan (agomelatine), posted by jrbecker on July 28, 2006, at 11:04:57
Sorry, I did not see this thread before I started my own on Valdoxan. I'm reposting my comments here to consolidate the threads:
The drug Agomelatine, under the brand name Valdoxan/Thymanax has been refused marketing authorization by the European Medicines Agency. Drug trials will continue and most likely Servier will request a re-hearing of the opinion.
http://www.pharmalive.com/News/index.cfm?articleid=361066&categoryid=51#
http://www.emea.eu.int/pdfs/human/opinion/ValdoxanThymanaxRefusalQ&A26770306.pdf
Novartis has purchased marketing rights from Servier for the United States, but any US approval is likely to be years away.
I am disappointed by the European decision. There was no evidence of any concern about safety, merely lack of sufficient evidence that it was superior to current antidepressants. The decision was the wrong one from both scientific and public policy viewpoints. It is well understood by now that new psychopharmacologic agents almost always help a subset of refractory patients even if in large trials they are on the average no better than current medications. It is unfortunate that the bureaucracy has ignored this clinically established fact. As a result many patients who might benefit from the medication will not be able to use it.
Let us hope that Servier continues to seek approval of this innovative drug with more success in the future.
I have no personal or financial connection with Laboratoires Servier.
PeterJ
poster:PeterJ
thread:671402
URL: http://www.dr-bob.org/babble/20060724/msgs/671746.html