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FDA approves Entyvio to treat ulcerative colitis and Crohn's disease

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Ulcerative Colitis
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Posted 5/20/2014 8:39 PM (GMT 0)
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398065.htm
Posted 5/20/2014 8:44 PM (GMT 0)
God help them if anymore people die miserable deaths from PML due to the FDA's negligence and inadequate testing.

For those who need it, best of luck with it. Just remember Takeda will tell you that it will "click" better if used in combination with other therapies like corticosteroid and immunosuppressant medications. There is no free lunch.
Posted 5/20/2014 8:48 PM (GMT 0)
I don't think there were any cases of PML in the clinical testings. Sounds like this is safer because it is more gut specific than Remicade, Humira and Simponi.
Posted 5/20/2014 8:51 PM (GMT 0)
No PML deaths. In fact this therapy has higher safety ratings than just about all UC treatments, including prednisone which I believe is called a first line therapy.
Posted 5/20/2014 9:11 PM (GMT 0)
I was just checking the data on safety here.

A total of 12 deaths occurred in patients who received VDZ; the FDA reviewer concluded that none of those deaths were related to VDZ.

In the comparative safety data, infections were higher overall in the VDZ group than the placebo (PBO) group (43% vs 35%), but serious infections were about the same across groups (4% in VDZ, 3% in PBO, and 3% in VDZ/PBO).

Upper respiratory tract infections were the most frequently reported infections (high-level term; 24% VDZ vs 17% PBO) and appear to have driven the difference in frequency of overall infections between the VDZ and PBO groups.

Herpes viral infections (none serious) were reported by 51 patients; most were oral herpes. Herpes infection rates were similar between the treatment groups (3% VDZ/PBO, 2% PBO, and 3% VDZ).

Not bad, initially. We'll see how this pans out.

Good to note about the PML deaths given Tysabri's history.
Posted 5/20/2014 9:29 PM (GMT 0)
that's great that it was approved. thanks for sharing!
Posted 5/20/2014 9:29 PM (GMT 0)
It's weird that the press release says it's an injection. I thought it was an infusion. I actually like the infusions, it's the only time I ever get the chance to read books.
Posted 5/20/2014 9:38 PM (GMT 0)
Been waiting for this. I'm on Humira and MTX but I'm just maintaining and not getting to remission. Hope to give this a shot in a couple of months. I been holding off on surgery since I have CD not UC and I don't consider surgery a cure for me at all. I wish I was still diagnosed with UC. Had a lot more hope then
Posted 5/20/2014 10:00 PM (GMT 0)
Glad to have confirmation that it was approved, but I dont think there was ever any doubt.

PML shouldnt be an issue with vedolizumab like it is for Natalizumab. Natalizumab targets both the a1b7 and the a4b7 intergrin, while vedolizumab targets only the a4b7. Since the PML is believed to be caused by blocking of a1b7, vedo should be ok.
Posted 5/20/2014 10:13 PM (GMT 0)
Great news!

Bad news is I just had to "ignore" someone again. I hate to do that.
Posted 5/21/2014 1:11 AM (GMT 0)
I think that's happening to a lot of people Judy!
Posted 5/21/2014 1:11 AM (GMT 0)
I think that's happening to a lot of people Judy!
Posted 5/21/2014 1:11 AM (GMT 0)
Great news! I have an appt. w/ my GI Friday am to discuss. Will pass on any info I get :)

I still have the option to go into a drug trail that is basically entyvio (it will be hard to stop saying vedilizumab) that is an injection given at home.
Posted 5/21/2014 1:12 AM (GMT 0)
My Simponi has been so so...and I will NOT see a surgeon as my GI has been so quick to suggest.

I will demand a look at this as my next option, since it is not a TNF.....my next appt is June 9 with him.
Posted 5/21/2014 1:20 AM (GMT 0)
This is great news, especially if it is an injection! We would still have freedom to travel without having to be in a certain place to sit for an infusion!
Posted 5/21/2014 1:23 AM (GMT 0)
^What was approved is an infusion. Based on what I have read the infusion takes less time than Remicade.
Posted 5/21/2014 2:21 AM (GMT 0)
For sure an infusion, takes aprox 30 minutes, not weight based. Safety profile pretty darn good, better than Tsabri, and the most excited GI 's have been in years. Site specific, so I am hopeful. Went the DDW this year in Chicago, and have had multiple GI interactions in the test phases. Should be out mid June. Waiting for the insurance Bs that is sure to follow. Who knows how it will be reimbursed.
I will grant you that it is our sincere hearts desire that it works, and know that it is still just a "shot" at more remission. But folks, the last 9 months have been hell, and the thought of remission is heaven like.
Mid June.Takeda gearing up, availability not just at test sites. Fingers crossed. Not many options for some of us....
Posted 5/21/2014 4:48 AM (GMT 0)
FINALLY an update!

I've been stalking this drug, like the hottest new celebrity.

With Remicade not getting me in the right direction, especially not fast enough...
I'd love to have another option to discuss with my GI! :)
Posted 5/21/2014 6:52 AM (GMT 0)
This is the most excited GIs have been in yrs. And for a good reason. This drug has a better safety profile than corticosteroids even! Forget other immunomodulators. And i read the reports from the clinical trials extensively. No cases of PML. And theoratically no risk either.

This is the start of a new era in UC treatment. Site specific immunomodulators are the treatments of the future.
Posted 5/21/2014 10:51 AM (GMT 0)
Everytime I see the name of this drug though, all I can think of is the Activia commercial- you now how they sing "Activiaaaaaa....!!!!"... well I'm singing "Entyvioooooo....!!!!!". I'll be anxious to hear if those of you who try it get some good remission. Watch, I knew they'd find a "cure" like a month after I had surgery! smilewinkgrin
Posted 5/21/2014 11:17 AM (GMT 0)
Let's hope Entyvio song will not end like Activia's song (it has been proven that Activia is a big scam, especially for children who become obese with it).
Vedolizumab seems great with great results, it's always mind-resting to know we have another treatment available in case of some failure of the other ones.
Posted 5/21/2014 11:40 AM (GMT 0)
Lol it's amazing how excited we get over a new medication. The biggest test is how it works once a number of us start using it. Most certainly, the safety profile looks much better than the tnf-alpha blocking biologics (remi, simponi, and humira) enough so that even gary and a few others are even considering taking it, if needed lol.
Posted 5/21/2014 12:59 PM (GMT 0)
^I need something to be excited about. Otherwise it is too depressing when you have taken every single thing available and failed them all.
Posted 5/21/2014 2:09 PM (GMT 0)
"At week six, 47.1 percent of patients receiving vedolizumab achieved clinical response compared to 25.5 percent of patients receiving placebo (p < 0.001), 16.9 percent achieved clinical remission versus 5.4 percent receiving placebo (p = 0.001), and 40.9 percent of vedolizumab-treated patients experienced mucosal healing compared to 24.8 percent of patients receiving placebo (p=0.001)."

"Of 895 patients enrolled, 373 met response criteria at six weeks (ITT population) and were randomized to receive vedolizumab 300 mg IV every four weeks (n=125) or eight weeks (n=122), or placebo (n=126) for up to 52 weeks. 41.8 percent and 44.8 percent of patients receiving vedolizumab every eight and four weeks, respectively, were in clinical remission at week 52, compared to 15.9 percent of patients who received placebo (p < 0.001). 56.6 percent and 52.0 percent of patients treated with vedolizumab every eight and four weeks, respectively, achieved durable clinical response (defined by a response at both week six and week 52), compared to 23.8 percent of patients receiving placebo (p=0.01, p < 0.001, respectively)."
Posted 5/21/2014 2:27 PM (GMT 0)
15.9% of this group of patients with moderate to severe active UC were in remission at week 52 taking a placebo. hmmmm
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