US FDA advisory panel backs approval of vedolizumab for CD

Ides

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Joined : Nov 2003

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Posted 12/14/2013 12:30 AM (GMT 0)

US FDA advisory panel backs approval of vedolizumab for CD
http://www.reuters.com/article/2013/12/10/us-takeda-fda-drug-idusbre9b817g20131210

Dave123

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Joined : Feb 2005

Posts : 238

Posted 12/14/2013 1:54 AM (GMT 0)

Does this mean it will be on the market or more steps in the process? How long?

Ides

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Posts : 7204

Posted 12/14/2013 2:19 AM (GMT 0)

The FDA is not obligated to comply with the panels recommendation but it usually does so. I am not sure how long until the FDA makes a decision. Just think it is good that there is another possible treatment available to people with CD.

Dave123

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Posts : 238

Posted 12/14/2013 2:26 AM (GMT 0)

I have been watching this drug for a while. I took Tysabri in it's trial stage and wasn't allowed into this vedolizumab trial because it was an exclusion criteria. Tysabri worked well for me and this works similar so I am anxious to see it approved. Especially glad to see no PML cases with the new one.

73monte

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Posts : 2519

Posted 12/14/2013 6:17 AM (GMT 0)

I too am glad to see that this will becoming available. Hopefully it will be a step up from our current treatment options.

sooper

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Posts : 815

Posted 12/14/2013 11:28 PM (GMT 0)

More poison to treat us.... I am always waiting to hear of something like a vitamin lol. I was hopeful back in 2003 during the VSL3 trial ran at my clinic, but alas it was too good to be true while it def helped it would not alone manage it.

Jen77

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Posts : 2742

Posted 12/15/2013 2:13 AM (GMT 0)

I'm glad to hear this, we need more treatment options. Yeah, I really doubt they'll ever find a vitamin to manage it alone.

JakeB

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Joined : Dec 2008

Posts : 164

Posted 12/16/2013 7:52 PM (GMT 0)

This is the medicine my doctor wants me on once it gets approved. I am currently on Tysabri, which seems to be helping the most of any. Though I hate the risks of PML (even though I was JC negative twice), and would definitely prefer something that is more specific to the intestinal tract.

cindywchrones

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Joined : Mar 2005

Posts : 1115

Posted 12/19/2013 7:33 PM (GMT 0)

I suffer from extra intestinal crohns symptoms which I require immunosuppresant drugs to contain a systemic response treatment options vary from person to person--I have a problem reacting to everything--most drugs I have been given--

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