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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by jrbecker on July 28, 2006, at 11:04:57
http://www.pharmalive.com/News/index.cfm?articleid=361066&categoryid=51
Posted by Tom Twilight on July 28, 2006, at 13:29:52
In reply to EMEA - refusal for Valdoxan (agomelatine), posted by jrbecker on July 28, 2006, at 11:04:57
What its not going to be aproved?!
Man the EU marketing body is worse than the FDA
This is a devistating blow
Posted by notfred on July 28, 2006, at 19:39:54
In reply to Re: EMEA - refusal for Valdoxan (agomelatine), posted by Tom Twilight on July 28, 2006, at 13:29:52
The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
1. • The long-term study did not show that the medicine was effective .
2. • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine’s effectiveness
Posted by River1924 on July 29, 2006, at 0:44:56
In reply to Re: EMEA - refusal for Valdoxan (agomelatine), posted by notfred on July 28, 2006, at 19:39:54
In my opinion, anything that isn't harmful and may help (even a small subgroup of individuals) should be allowed into the marketplace. I don't think FDA or EU has to "approve" it as in give it the organizations seal of approval. Maybe another category could be created. "Generally Safe Drugs of Uncertain or Limited Effectiveness." Insurance needn't be compelled to cover it but, when one has tried everything else, why not give me a chance.
Really. there are thousands of chemicals which are in industrial products that haven't had any real testing... yet we are allowed to absorb them through air and water.
I find the whole system bizarre. Plus, at least as concerns the FDA... I tend to think giant US companies have a far better chance of getting drugs through the system... not because they are better drugs but the companies have better connections.
Oh vay. R.
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
Posted by SLS on July 29, 2006, at 19:02:21
In reply to Re: EMEA - refusal for Valdoxan (agomelatine), posted by PeterJ on July 29, 2006, at 11:12:20
Hi PJ.
It's nice to see you posting again after so long an absence. I hope your suprachiasmatic nucleus has been treating you well.
:-)
- Scott
Posted by peradd on July 31, 2006, at 5:51:10
In reply to Re: EMEA - refusal for Valdoxan (agomelatine), posted by PeterJ on July 29, 2006, at 11:12:20
Anyone who knows if the company Servier has applied for use of Valdoxan in other markets like Asia, South America, Russia ? Their Stablon_Tianpetine is available there, but not i many EU countries and not in the USA. Then it would be possibly to get it mailorder...hopefully soon.
Per
> 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
Posted by cecyl79 on August 15, 2006, at 7:28:47
In reply to Re: EMEA - refusal for Valdoxan (agomelatine) » PeterJ, posted by peradd on July 31, 2006, at 5:51:10
Hi !
Anyone knows if Servier have requested re-examination of the EMEA opinion ?
Cecyl
This is the end of the thread.
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