FDA Update on Approving Abbott’s Humira Medication for Colitis

Adam iHaveUC colitisHey UC’ers, how the heck you all doing?

Here’s my first post since getting back from my camping/rafting trip and its not a typical one, but because I get so much email and there’s so much chatter about Humira amongst the colitis folks of the world, I thought this would be of interest to many of you who might be making medication decisions if you’re treating your UC that way.  And at the same time, I thought it would be a nice opportunity to come way out of the closet and make darn sure that all users of the site realize that just because I don’t use medications to treat my UC, I know a HUGE chunk of you do.  And that is awesome, especially if you’re getting great results.  The reality is that there’s so many options on how to treat UC, and it’s so easy for you (me) to think you know “the best” thing when it’s working for you…….BUTT, let’s not fool ourselves, positive results come in many shapes, sizes, forms, capsules, yoga moves, food, drink and whatever else.  Do you feel what I’m trying to get at here???  If you’re popping pills, or shooting up meds, getting your colon removed…whatever the case may be, it is a free world, and hopefully always will be.  And if you’re cranking good results that you’re happy with, right on amigos!  (now back to the original broadcast…)

Earlier today the Food and Drug Administration (FDA) released an update regarding their review of the medication Humira for the intended treatment of ulcerative colitis. The GIDAC (Gastroenterologist Drugs Advisory Committee) will be holding a formal meeting on Tuesday August 28, 2012 to vote on the potential approval of Humira.

Within the FDA’s formal review, they explain how Abbott Labratories (the producer of Humira) has proposed the following:

“HUMIRA is indicated for reducing signs and symptoms, and inducing and maintaining induction of clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.”

There has already been some lengthy discussion between Abbott and the FDA regarding Humira and Ulcerative Colitis in the past, back in January of 2011, Abbott had submitted some documentation to the FDA about efficacy studies regarding UC patients and Humira, however the FDA requested more information to help determine if Humira was something which should be approved to treat UC.

Two Files You Can Download and Read Now:

Most recently, Abbott prepared a formal response to the FDA (in PDF format): Abbott Labs Humira FDA Information

And

The current FDA briefing information in response to Abbott’s documentation submitted above: FDA August 28 2012 Humira Review Response

(you can find both of these files also on the FDA website)

If you are interested in learning about the FDA approval process for new medications, such as this biologic medication Humira (which is expected to bring in over $1 Billion in sales to Abbott if approved in the US for UC) you might enjoy reading through the summaries which are the first sections of both of the pdf files listed above.  I myself learned quite a bit in reading through them early this morning.

What was praticularly interesting for me to learn was how the Food and Drug Administration feels about treatment options for our disease.  Below is a direct reference from the second PDF file listed above:

Current Treatment Options for Ulcerative Colitis
Decisions about treatment of UC weigh such factors as disease activity, disease extent and duration, previous treatment attempts and the patient’s preference. The goal is to stop the patient’s active acute disease (induction of remission) and then maintain the patient in remission.

Aminosalicylate preparations, given orally, rectally or in combination, are the first line of treatment for induction of remission (aminosalicylates are approved to treat mildly or moderately active UC including, for certain products, maintenance of remission). Patients with mild-to-moderate UC that is refractory to aminosalicylates are often advanced to oral corticosteroids (approved to “tide the patient over a critical period”) and immunosuppressive agents (e.g., azathioprine or 6-mercaptopurine; widely used but unapproved). Use of any of the preceding has come to be considered part of “conventional therapy.”

Currently, Remicade (infliximab) is the only TNFα-antagonist approved for induction and maintenance of remission in patients with moderately to severely active UC who have inadequate response to conventional therapy. Remicade has been shown to be effective in this population and has an acceptable safety profile; however, many patients do not respond initially, lose response over time, and/or develop intolerance.

Colectomy is still required for many when medical therapy fails or when epithelial dysplasia is found on surveillance. Total proctocolectomy with ileal pouch–anal anastomosis (IPAA) is currently the procedure of choice because it preserves anal sphincter function. While the mortality of the procedure is low, long-term morbidity is not. Pouchitis, often intermittent and recurrent, is a prevalent problem with symptoms that include increased stool frequency, urgency, incontinence, seepage, and abdominal and perianal discomfort.

(It’s called the “Food and Drug Administration” right?…Well…why the heck is there NO mention of food in the excerpt above?)

So for anybody who is interested in learning more about Humira, and what may/may not happen on Tuesday, stay tuned.  I’m sure there will be some big final news after the FDA vote coming up which might affect some of you and your decision making.

As some of you might remember, back when I was using medications to treat my UC, I had a pretty awful experience myself with Humira.  It was not an approved medication by the FDA, but I was able to get insurance clearance for it and gave it a go.  You can read more about my humira experience here if you like along with many comments from other UC’ers.

Have a great weekend everyone, lots more UC stories I’ll be posting on the site in the coming days from those of you who have submitted your stories and pictures.

Adam Scheuer

Tags: Humira





21 Responses to “FDA Update on Approving Abbott’s Humira Medication for Colitis”

  1. LaurieAugust 24, 2012 at 12:09 pm #

    After 3 months of very active and painful (not going to work, either) UC, I thought I was in remission…2 weeks of “normal” body function. Two days ago, another flare! I am so frustrated!

    • BevAugust 26, 2012 at 8:04 am #

      Hey Laurie..

      Good old UC, huh? Typical of it to screw with your life that way.

      This flare, too, shall pass. They always pass…some quicker than others.

      Keep up the good fight…and the positive attitudity!!

  2. BevAugust 24, 2012 at 1:33 pm #

    Hey Adam

    Sheesh…this is kind of unbelievable! As you said, diet remains unmentionable in the treatment for UC (even tho this excerpt is from the food and drug admin), as well as probiotics or other ‘unproven’ alternative therapies. Obviously, all of the things mentioned, eventually cease to work at retaining remission, anyway. That is not stated, however. It’s always ‘the goal is to obtain and retain remission’.

    It seems these sorts of ‘recommendations’ and ‘findings’ always ‘beat around the bush’. Nothing is ever proven to work 100%, nor do they tell us that. You have to read betweenb the lines to realize that nothing is really known about this so called ‘disease’.

    Thanks Adam! Once again…more food for thought!

    • AdamAugust 25, 2012 at 10:37 am #

      It all is kinda strange to learn more about the whole FDA approval process. And its very hard for the average person who’s actually paying for these types of medications to get down and dirty and read all the lines, but thankfully there are options for us UC’ers and I was even surprised to learn that people from the general public can attend and even participate with written/oral statements at these types of meetings. So, if you/me are ever out there in Silverspring Maryland (I worked out there once believe it or not) maybe we should crash a FDA meeting together;)
      -Adam

      • BevAugust 26, 2012 at 8:02 am #

        Right with you Adam.

        True that!

  3. shelly in maineAugust 24, 2012 at 5:01 pm #

    Hey Adam,
    Welcome back and right out of the gate with a vengeance! Feels like we’ve gone full circle…it was over 2 years ago we chatted about remicade and humira-the gift that keeps on giving! To others reading I basically am pretty sure I needed it-regretfully-as I had been off meds. After a remicade allergy and doing something similar to SCD and got my first cold early Nov. And then 2 more right off the bat I work with spec. ed. Students in a prek-8 school-one of the germ capitals of the world! Anyway, fast and furious about 25 x a day and bleeding -out of work for over a month and not wanting defeat-i waited for 2 weeks more to get denied, denied, denied and finally approved. It took a while to work, but it eventually stopped the bleeding, had to have a heart stress test (had one on remicade too)to make sure it wasn’t causing heart failure or issues-and I know I was allergic the whole time until I finally ended up in the ER within 6 months…but I did stop bleeding and saved my innards-at what cost?? Not sure that was the only choice i really had to save myself.
    Hind sight? Regret. Do it again? Probably not. Will not do any more toxic Meds.
    By the way last I knew it had a black box warning.
    Read a lot about it and read other people’s experiences so you can make informed decisions about this or any other treatments.
    Thanks as always Adam for the platform and the rant.
    Best and good health, Shelly-med. Free for over a year and counting. :-)

    • AdamAugust 25, 2012 at 10:45 am #

      Whats up Shelly!
      (Nice rant BTW:)

      Over a year, yippie, music to my ears! Congrats to you bigtime on that. I know its been a tough road for you to get to this point with many bumps, but you’re doing it and that’s great.

      HOpefully enjoying the rest of the summertime up there in the top right corner!

      Take care,

      -Adam

    • BevAugust 26, 2012 at 8:10 am #

      Fab Shelly…FAB!!

      Those damned drugs. Heart failure? Seriously? This is why I can’t even consider drugs at all anymore. If my heart, liver, or kidneys get ‘hurt’…where on earth will I be then? Where? Who will even care?

      Doctors seem to actually get angry with us when we take control of our own bodies. Well, no shit, Sherlock…what do you expect, doc? Our med choices suck.

      I’m so very happy for you my friend!! More success stories please everyone…let’s help ourselves, and cure ourselves!!! We have to do it ourselves. WE GIVE A SHIT!!! (Again…no pun intended…it’s hard not to make evry ‘shit’ and ‘crap’ a joke with this UC thing ain’t it?!)

      Bev…a succes story in progress:):):)

      • shelly in maineAugust 26, 2012 at 1:02 pm #

        :-) thanks… Yeah and you, too -Fab….let’s keep it going! :-)

  4. umaAugust 24, 2012 at 7:08 pm #

    Diet and probiotics and life style changes have not been mentioned . Well they have to make their billions, cant blame them,

    we have to watch out for ourselves. I think the probiotic’s manufacturers have to make their case to the FDA i am sure Bev

    and i will vouch for them. I know a cousin of mine who started probiotics after i told her my story and she mentioned it to

    her doctor. The doc asked her to stop it as it was not FDA approved and she stopped taking it.

    • AdamAugust 25, 2012 at 10:47 am #

      Hey Uma,

      I think you should definitely show up there at the FDA, and get ahold of the GI Advisory Group there and ask them straight up how difficult it would/would not be to get probiotics “officially blessed” by them. Who knows, it might not be too hard, but it would be interesting to investigate if there have been attempts so far or not at just this.
      Great to hear from you and hope you’re doing well,

      -Adam

    • BevAugust 26, 2012 at 8:11 am #

      Sheesh…those doctors…

  5. SteveAugust 24, 2012 at 7:30 pm #

    Thanks Adam for the good read once again.

    I have read one story out of many on this site where a person took the same medication long-term and was said to be in remission. For everyone else, it is a constant war…literally like a battle here at Gettysburg where we volley at the illness with medications, they work for a bit, then the disease volleys back, leaving us to have to try a new medication to mount an attack with that cycle repeating over and over.

    Stupid analogy maybe…but what if UC is the body’s way of trying to cleanse itself? What if every time a medication works then fails, or fails from the start, it is really the body defeating the toxic medication because the body still is trying to be healthy and cleanse itself? I don’t really want to rant because I get it…some people are satisfied with their treatments…but our doctors were never trained to analyze the human body for the amazing machine it is. Their treatments are hindering it from recovery…and in response, our bodies try that much harder(making the illness appear stronger/more progressive when it is not) and eventually there is no more fight left.

    I always use the analogy of spoiled milk. Take a gallon out on a hot day. Let it sit there for a while until it gets really nasty. Most people wouldn’t be able to stand the stench let alone try to drink it. Why? Because just from smelling it, the body can recognize how horribly bad it would make us sick. The same happens when we smell rotting meat…not because it just stinks. Our bodies are saying, “Please don’t eat that!” If you did manage to ignore that reaction and drink some milk or eat the spoiled meat, you would be hurling your guts out for a while. Again, why? The body has to protect itself and it will do that at all costs. UC, in a larger way, is very much the same process and all the body wants is to recover. When given the chance, it almost always will…only hindered by the damage already done and the length of the illness. No more rants for me for a while. :)

    On to less ranting news, I hope you all have a great day! Anyone know what the fish said to the concrete wall?

    • AdamAugust 25, 2012 at 10:49 am #

      I like the analogy Steve!

      I think i can smell the nasty milk right now…

      So what did the fish say?

      • SteveAugust 25, 2012 at 1:25 pm #

        lol. Dam.

    • BevAugust 26, 2012 at 8:13 am #

      OMFG Steve!!

      That, is fantastic. Our bodies cleaning out those bad drugs…very very thought provoking…

  6. BevAugust 26, 2012 at 8:14 am #

    This is ONE great thread, here. We are all getting so strong…can anyone else feel it???

  7. Johnny Drama
    JohnnyDramaAugust 26, 2012 at 5:31 pm #

    Adam,
    This is a great post! Its crazy to see how this process works and all of the bs these company’s say an do! Great stuff man, its a blessing to have a guy like you always looking out for us UC’ers and always taking the time to investigate and get down to the bottom of these kind of topics.
    Hope you had a good vaca and I look forward to the rest of this article

    • AdamAugust 26, 2012 at 6:16 pm #

      Thx JD,

      Great to hear from you, get your butt on out to DC and get in on the next FDA meeting! They need some folks like you out there knocking heads!
      hope you’re well,
      -Adam

  8. Almosthuman
    Leila HuhmanAugust 28, 2012 at 4:44 pm #

    Hi Adam,
    I am new to the site and wondering if there has been any discussion about CBDs. I live in California where medical marijuana is legal but I don’t like to be stoned. CBD stands for cannabidiol, which is mj that has had the THC bred out, but leaves all the other anti-inflammatory molecules. So you can get relief without ruining your day. It is a tincture that you squirt under your tongue.
    Love your puns,
    Leila Huhman

    • AdamAugust 28, 2012 at 7:00 pm #

      Hey Leila,

      Pretty neat what you’re talking about. I myself don’t have any experience with that nor have I heard much discussion about that on this site yet. But hey, there’s all types of way to get from A to B, and just because I haven’t heard about that yet, sure doesn’t mean it might not be very beneficial. There’s a doc in SF who’s got a website http://www.potdoc.com who is pretty knowledgable about most things cannabis related. You might want to try and email/contact him and see if he has any ideas on that topic.

      -Adam

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