Could there be leaks from the meeting this week ?
Also, CHMP published a list of medicines requiring additional monitoring today, and Lorcaserin WAS NOT
on it. So does that mean Lorcaserin is now approved ?
PRAC in the EMA was born on July 2012; prior to that there was no PRAC
Currently PRAC is trying to catch up on all the products that are already on the market. The gist of the list is intended ONLY for medicines that are already authorized or approved and are with the post-approval pre-authorization phase. Also, the list contains medicines that either 1) contain a new substance 2) limited post-marketing experience 3) approved under exceptional circumstances or 4) medicines that require a Post-Authorization Safety Study (PASS)
As far as Lorcaserin is concerned; if Lorc already got the nod today; then, Lorc will have to be on the PRAC list next month simply because it is an New Chemical Entity.
Medicines that are subject to additional monitoring are:
• medicines authorised after 1 January 2011 that contain a new active substance;
• biological medicines for which there is limited post-marketing experience;
• medicines with a conditional approval or approved under exceptional circumstances;
• medicines for which the marketing-authorisation holder is required to carry out a postauthorisation safety study (PASS).
If you are really smart than you should know that Lorcaserin definitely needs some additional monitoring. No additional monitoring means rejection. All those with additional monitoring were approved while not on the list were rejected.