Update on Crohn's drug!!

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Date Joined Jul 2006
Total Posts : 276
   Posted 10/15/2007 11:16 AM (GMT -7)   
Elan, Biogen Idec Say FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease Elan and Biogen Idec announced that the FDA will extend its regulatory review of Tysabri as a treatment for Crohn’s disease by up to three months. The agency requires additional time to review information regarding the proposed Tysabri risk management plan for Crohn's disease. Under this revised timeline, the companies anticipate action from FDA on or before Jan. 13, 2008. (Elan/Biogen joint press release)  
UC since 1986.

Asacol - four a day
6 MP - one a day.
Remicade - every eight weeks.

Veteran Member

Date Joined Mar 2007
Total Posts : 4527
   Posted 10/15/2007 4:57 PM (GMT -7)   
Hi Thanks for the info. lol gail

Regular Member

Date Joined May 2006
Total Posts : 167
   Posted 10/17/2007 9:21 PM (GMT -7)   
Thanks for the info, another drug on the market is good, more choices and options.
DX with CD at 22 (23 now)
Tried Pentasa and Entocort, worked for a yr and a bit
Now on prednisone 40mg and going crazy!

Veteran Member

Date Joined Feb 2007
Total Posts : 1010
   Posted 10/18/2007 6:10 AM (GMT -7)   
I bet the press release did not explain that Tysabri was pulled from the market, and clinical trials of Crohn's diseases and rheumatoid arthritis were suspended because during the trials two patients (that's people like you and me) developed progressive multifocal leukoencephalopathy. This is a deadly disease of the brain that progressively and fataly demyelinates the central nervous system. It is typically seen in immunosuppressed individuals. How does tysarbi work? By suppressing the immune system. There might be some of us out there so desperately ill that the decision to use tysarbi is warranted, but ...

The problem with all these new drugs is that they all have their proponents -- drug companies with huge investments -- who are sometimes less willing to give consumers the straight story. Crohn's patients live with the knowledge that they will have to play dodge the bullet with medications over the lifetime of their illness. We can only make the decisions that are best for us if we have all the facts.

For my money, rather than jump on the bandwagon and push to get to the front of the line to get every new drug that comes on the market, my plan is to stick -- as much as possible -- with the older classes of medications whose track records have been established.

30+ years living with Crohn's.

Regular Member

Date Joined Oct 2006
Total Posts : 367
   Posted 10/19/2007 8:34 AM (GMT -7)   
All that Bellennstein said about Tysabri is true. But did you know the reason why it is being looked at again by the FDA? Tysabri is also indicated for MS. And it has been a really, really good drug for MS. So when Tysabri was pulled from the market, the MS patients and doctors lobbied hard to have it back.

I don't know if there has been any reformulation of the drug or changes in recommended dosage. But the fact is that someone out there has a disease that is so bad and they respond to the drug so well, that they are willing to take the chance.

Veteran Member

Date Joined May 2003
Total Posts : 9448
   Posted 10/19/2007 11:05 AM (GMT -7)   
But that is always the decision facing us w/every drug for our illness, whatever that illness is. We have to weigh the risks vs our quality of life - or even w/some illnesses w/our life itself.

I thank God each and every day that my Crohn's has remained mild enough that Imuran has kept me fairly comfortable and in and out of symptomatic remission. I hope to never have to consider the options of the biologics such as Remicade, Humira, etc. despite the wonders they have done for some crohnies.

On the other hand, I am grateful that they are an option for those who need more than Imuran or 6MP can provide.
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.

Terry in Virginia
New Member

Date Joined Oct 2007
Total Posts : 9
   Posted 10/19/2007 12:13 PM (GMT -7)   
Thanks for the update. While we've seen that many of the newer DNA-based drugs can have widely varied results and risky side-effects, I for one hope to see Elan's medicine available. I was in the clinical trials for it a couple years back until they were stopped. So far, it has been the ONLY medicine that's done anything to reduce my CD symptons over the past 12 years.

Newbie (and first post here)

Terry in Virginia
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