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Vedolizumab Approval Date?

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Ulcerative Colitis
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Posted 3/31/2014 9:29 PM (GMT 0)
Sorry if this has been brought up already, but does anyone know when Vedolizumab is supposed to approved by the FDA for UC? Ive read in a few places it was supposed to be on Feb 18th, 2014, but obviously that date has come and gone and I have not heard any new news about it.

Thanks in advance!
Posted 3/31/2014 9:42 PM (GMT 0)
May 20th is the action date for approval. It was extended from Feb to give the FDA more time to review. It was already approved by the advisory committee so hopefully it will be just a formality for full approval in May.
Posted 3/31/2014 11:05 PM (GMT 0)
^My GI told me the same date last week. Then said once it was approved was take a little bit to get the Remicade nurse set up to administer the vedolizumab. I also talked to the research nurse (my GI's office was in the drug trials) and she said is a faster infusion than Remicade. So that's nice. They didn't have a ton more information on definite dates.

I'm in a holding pattern waiting to try this or go into another drug trial.
Posted 3/31/2014 11:24 PM (GMT 0)
Great, thanks for the info guys!
Posted 4/1/2014 12:39 AM (GMT 0)
It may take some additional time for your insurance company to add it to their formulary and their computer systems. I had this problem last year when Simponi was first approved. Your GI's office may help expedite this with your insurance company but it does take time.
Posted 4/1/2014 12:43 AM (GMT 0)
Yeah. Don't expect the insurance companies to be tripping over each other to approve this.
Posted 4/1/2014 1:44 AM (GMT 0)
Other than quicker infusion, what are the advantages of the new one? Or is it just different enough that it will help those who've developed antibodies to remicade?
Posted 4/1/2014 2:13 AM (GMT 0)
Vedolizumab works totally differently than most of the other biologics and has an excellent safety profile. It is not just another Remicade, Humira, Simponi, etc. It has been talked about as being a first line therapy such as the 5 ASA's, etc. Since it will probably be extremely expensive I don't know if it is realistic to actually make it to being a first line therapy but I would actually consider taking it when I would not even consider the other biologics, unless I was in horrible condition. Even then, I would like to think I would choose surgery over Remicade, Humira, and the others. They have too many side effects where Vedolizumab is pretty much side effect free, including cancers.
Posted 4/2/2014 3:17 AM (GMT 0)
When is this being released in Canada?
Posted 4/2/2014 8:25 PM (GMT 0)
That is great that it will be soon be approved.

I have been on the Vedolizumab trial for around 4 years now, and have been in remission the whole time.

I am in the UK, so I dont know when it will be approved here. Despite being on the trial, we are told very little about how the approval process is going.

The makers of Vedolizumab recently told me and the other patients on the trial at my hospital that we can stay on it until the UK NHS approves it. Which is a huge relief.

Best wishes
Posted 4/2/2014 9:54 PM (GMT 0)
Just curious - Are you absolutely totally 100 % in remission? I mean not even one symptom, even occasionally?
Posted 4/2/2014 10:53 PM (GMT 0)
Hey barnsbury! Nice of you to drop by!

You posted that your remission ended almost a year ago here.

Were you able to resolve your issues. And if so, how?

Thanks.
Posted 4/3/2014 2:08 AM (GMT 0)
Gary, thanks for the clarification, I had no idea! It sounds very promising!
Posted 4/3/2014 8:04 AM (GMT 0)
Hi everyone

Thanks. I havent been on this site for a long time so thought I would see what was going on.

Garylousiville - My only symptom is some urgency when I first get out of bed in the mornings. But, I have been told that I will have this forever, due to having so much scar tissue because of my long repeated flares over the years. Apart from that, I have a normal life. Its a minor inconvenience.

Gerasim - I had totally forgot about that incident! It turned out that episode last year was not a flare after all. I had a colonoscopy and they found zero inflammation. Nothing at all. In fact, it never looked better.

I had a reaction to the Hepatitis A vaccine and this gave me bad diarrhoea. It all resolved itself after a couple of months. Needless to say, I have not dared to go back to get the 2nd course of vaccination injections! Absolutely not worth it.

So, apart from that, everything has been fine.

Take care
Posted 4/3/2014 12:18 PM (GMT 0)
Wow Barnbury, that is awesome! Any side effects from the Vedo?
B
Posted 4/3/2014 12:35 PM (GMT 0)
I have had the following side effects:

- Nose pain (Intermittent, happens for a few days every few months)

- Mild sore throat (Again, intermittant)

- Nightmares/Night terrors (This was really bad in the early months of treatment but now I never get them - I recently discovered another patient on the trial also experienced this at the start of her treatment. Very strange.

- Poor wound healing


So, nothing major I guess.
Posted 4/3/2014 2:42 PM (GMT 0)
Thanks, that is very interesting.
B
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