New Drug

[TammySue62]

Hi EVERYONE
I herd of a new drug thats used for crohn's called CIMZIA
Has anyone herd of this drug or is anyone using this drug.
But of course it is not available in Canada yet.

TAMMY

 

[Kev]

Never heard of it till now. Varioius websites seem to have info that's 2 yrs old. They talk about the precise 1 N 2 trials, and mention phase 3 N 4 trials (precise 3 N 4) that are 2 yr trials as a followup on the folks who took it in precise 1 N 2, just to see if there are long term side effects or risks. Saw something from Europe from Oct/05 where makers had applied for FDA approval AND a note about Canadas' role in the development in JAMA. I've yet to see whether it has been given approval, or results from precise 3 N 4

The numbers on remission or symptom reduction look promising, but it seems to still be in the early phases of testing, else too new for a lot of drs to get onside with... esp. w/o the results of the long term effects testing..

 

[soupdragon69]

Have done a quick trawl on the UK sites just now.

Its a human anti TNF alpha drug. So a human version of infliximab (which has a small element of mouse protein in it). Is given subcut like Humira.

Generic name for it is Certolizumab Pegol. Still not licensed here but used in clinical trials for induction of remission and maintenance of moderate to severe Crohn's.

This info is dated March 07.

The link is http://www.nice.org.uk/download.aspx.?o=414168


Not sure if it will work...

 

[Kev]

You were right, link hiccups.. Says the resource is not found. But it gives you a link to their homepage, and if one types in CIMZIA, that takes you to links to the top articles. When I did it, there were 4, dated from various times in 07

 

[soupdragon69]

Thought as much. The one I looked at is entitled: Appendix A
Health Technology Appraisal

Use of TNF inhibitors (adalimimab, certolizumab and infliximab (review)) and natalizumab for Crohn's Disease.

Draft Scope


Its 4 pages long and issued March 2007

That help? lol

 

[D Bergy]

If you do a search on Cimzia here on the forum you can see the other posts about it.

Dan Bergman

 

[Kev]

Did as you suggested Dan. interesting to see how many prior posts that word came up in. I must be getting old (as opposed to what?), but I'd read most of those posts, yet the word didn't trigger any memories. Too many brand names.. However, the search triggered another question.. anyone seen/heard from Old Hat lately. I know it's OT, but he's been awfully quiet of late. hope he is OK. As for cimzia, apparently it might be approved soon.

 

[D Bergy]

I have been wondering where he is myself. Maybe he is busy. I miss his in depth research. I like argueing with him also. Sounds weird, but I always like people I argue with. Maybe that is why I got married.

I will be moving to a new house this month so if I disappear for a while it is because I am breaking my back moving.

Dan Bergman

 

[soupdragon69]

Yes I agree with you boys about Old Hat, have really missed his input here.

Like your thinking Dan about why you got married! lol However, please come back to us in one piece after your move ok?

 

[Tom]

I live in Belgium and Cimzia is manufactured by a Belgian firm. I know a lot of patients in Belgium who receive Cimzia in a trial. You can compare it with Remicade, but better with Humira (injections, 100% full human antibody).

I believe that it's expected to come available for patiënts at the end of 2008 in Europe (after a succesfull registration)

Excuse me for my English, because I'm Dutch speaking

 

[Kev]

Hey Tom, Welcome to the forum. Nice of you to post that info. Interesting reading. Is Tom your name, or have you translated it for us? Reason I ask is that one of my closest friends (their farm was 3rd one over from ours) was of Dutch descent (2nd generation) and his name was Jon (we called him Johnny)
but it wasn't spelled that way. BTW, your English is excellent, better than mine.. Anyway, always nice to welcome a new member.

 

[saidinstouch]

cimzia is manufacture by a company named ucb pharmaceuticals. They sponsor a website called www.crohnsandme.com (I should read if linking to other sites is allowed or not and if it isn't please let me know or correct this for me). It was submitted for its BLA (Biologics License Application) around the same time as Humira, only Humira was able to get the fast track of approval due to the fact it was already approved for rheumatoid arthritis and so the safety and tolerability had already been proven.

One difference in cimzia is that it is pegolate, I'm not quite sure what this process entails, but it can increase the dosing range to once every 4 weeks unlike every 2 weeks with humira. If you want more information a quick google search of cimzia brings up quite a bit of information about the drug and the information looks fairly promising. I would say the questions isn't if it will be approved, but when and what the cost will be.

 

[Tom]

Hey Tom, Welcome to the forum. Nice of you to post that info. Interesting reading. Is Tom your name, or have you translated it for us?

My name is really Tom . It's a popular name in Dutch speaking countries, because we have a lot of influences of English and German .


About Cimzia: the European regulators have disapproved the use of Cimzia for Crohn's Disease in Europe. Have a look at http://www.ucb-group.com

 

[Kev]

Hey Tom.. Learn something new everyday.. eeer, in this case, two actually. I wasn't aware that Tom was such a popular name there. There's a certain kind of afinity, almost kinship, between Canada and the Netherlands dating back to the last war.. As for CIMZIA, wow, that info is hot off the press as they say. Shame that it doesn't discuss why they've ruled it out for crohns.

 

[pnp26]

I just started cimzia, it came to the states about 2 weeks ago, it is like getting remicade but without waiting 3 hour for the infusion to end and with longer and better results, at least this is what i am hoping

 

[AbstractDonut]

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html