Posted by Marty on November 22, 2008, at 12:29:20
In reply to Re: Agomelatine - approved in Europe, posted by jrbecker76 on November 22, 2008, at 9:24:49
I agree. But regarding North America not only it could take a couple years but it also could never happen. The pretext would be the "common abnormalities of liver function tests (transaminase elevation > 3xULN)" vs the results (about half trial didn't show superiority over placebo) vs the positioning of Agomelatine: a light and easy AD (think Wellbutrin). While I say 'pretext' I think it would be of serious consideration but officiously more consideration could be given to market protectionism. Can you name a neuro/psycho pharmacologic drug by Servier marketed in North America ? I can't name one by Servier that didn't deserve to be approved here.. not even (especially?) Amineptine (Survector).If they (FDA/Health Canada) are to refuse Agomelatine because of health risks, AT LEAST they should consider a way to give easy access to the treatment resistant sufferers. A kind of special program but fast tracked: Did your patient failed at least 2 antidepressants from the 3 major class ? Yes ? Ok, is his liver functions checked and good ? Yes ? No prob.. just fax the form and attach a copy of the liver test results. That's it.. that shouldn't be more complicated than that.
/\/\arty---
> Consider Agomelatine approved. The EC completely relies on the EMEA's CHMP subcommittee for its opinion. In terms of market launch though, there will now have to be some regulatory and pricing determinations made in each EU country, so a good approximate time frame for Servier to be able to get to market is around 6 months (each country will vary in timing).
>
> http://www.servier.com/Pro/ContentPro.aspx?id=1181&=redirect
>
>
> It might be a little longer for us on this side of the water. Novartis has now delayed its plan to submit agomelatine (AG) 178) until the 1st half of 09.
>
> JB
poster:Marty
thread:864397
URL: http://www.dr-bob.org/babble/20081114/msgs/864634.html