Posted by Marty on September 24, 2008, at 16:01:06
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by Nadezda on September 24, 2008, at 9:53:22
> the drug companies make decision based on profits-- and costs of developing things--
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Hi Nadezda,The letter/petition would be for the people who approves the drugs (FDA/EMEA), not the pharmaceutical companies. In this case it would be to both FDA and EMEA regarding Agomelatine. We would encourage them to approve Valdoxan (Agomelatine) on the basis that as a new class of atypical antidepressant (new mechanism of action) it could help many treatment resistant sufferers. The point is that because it's an atypical of a new class it doesn't need to be superior to already marketted ADs. Think about it: What's best ?
A) a new AD of an already existing class which would be effective for more people than the others of the same class. (ex. New-AD 56% vs Old-ADs 49%)
B) a new AD of a new class who would works for less people than other ADs already on the market (ex. New-AD 44% vs Old-AD 49%) BUT would works for lets say 15% of the treatment resistant people. (because it works in a new way..)
I vote for B. The problems is that what the FDA/EMEA are looking to approve is ADs SUPERIOR in terms of how much people helps and to which extent, NOT ADs which are inferior on those terms but DIFFERENT and so works for people for who the 'more-of-the-same-thing' ADs doesn't helps much.In 20 years from now, I think it would be best to have enough different ADs to be able to help 100% of the people THAN to have fewer but superior (in terms of responders %) so that the Treatment-Responder people would have to try less ADs before finding the good one for them BUT having in 2028 about the same amount of treatment- resistant people.
Those Atypical ADs should be fasttracked as soon as they are proven SAFE and AS GOOD as any decent antidepressants on the market.
Is that your feeling too ?
/\/\arty
poster:Marty
thread:853681
URL: http://www.dr-bob.org/babble/20080915/msgs/853830.html