Humira and children in the EU

[Misty-Eyed]

Wasn't sure if I should put it here or in the Humira forum.

But good news! Humira got approved in the EU for 6-17 year olds!!!

http://www.pharmatimes.com/Article/12-11-27/Abbott_s_Humira_approved_in_EU_for_paediatric_Crohn_s.aspx

Hope everyone is doing ok

 

[my little penguin]

Thanks for the update!!!!

 

[izzi'smom]

Wondering why the cutoff is six...but glad to hear of it!
The first thing our insurance company asked us was for studies re: efficiacy in children, which didn't exist. Wondering if any are in the works?!

 

[Misty-Eyed]

Probably because there wasn't any participants in the study under 6 to prove the risk/benefit ratio.

I don't really know how these things work in the USA but here in the EU, Abbott who make Humira submitted what's called a PIP (paediatric investigational plan) in which it has actually carried out some studies in children to prove it's safe in children and has a good risk/benefit ratio.

But this could be good for you because now there has been studies carried out and from experience the EMA (European Medicines Agency) are harder to get an approval in than in the states.

I'll honestly have a good dig around later when I am home but for now you can find the name of the study in this document;

http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500108700.pdf

 

[hbonsky]

Thats great. I know people who have had success with that here. My son took it here at age 4 and it didn't work, but he is a rare case. He even went up to an adult dosage which my doctor allowed and I read that it actually was not a good idea.