tysabri fda

I've been tested twice in the last year, and they were both negative. Since you can acquire JCV at any time, I opt to have my status tested once a year since I'm on Tysabri. There is also a Tysabri antibody titre available, now. I plan on doing that once a year, too, although development of Tysabri antibodies is relatively rare.

Hi DH - Welcome to our group. I am currently getting Rituxan (rituxmab) and before this I was on Tysabri. They are the only two DMDs I've been on. I have had good experience with both meds. Tysabri lasted about 20 infusions before it stopped working. The Rituxan seems to be doing the job now. I started Rituxan in November of last year and finished my second round yesterday. I had no adverse reaction of any kind to either med.

Found out yesterday that I have to take 50,000 units of vitamin d to bring that number up. And I'm starting Tysabri. Really don't know what to expect. I would appreciate, anyone who has been on Tysabri, let me know what to expect while on it????

Yikes. That article doesn't make it sound like the FDA is out of line on this at all. In the risk-benefit ratio, it would seem this one doesn't stack up. I'm a bit confused by the phrasing 'FDA staff says' though, versus 'The FDA states'. Is this just an unnamed source situation?

Hey Guys, Just wanted to give you all a heads up, in the interest of us all being informed patients... :) I saw this article this morning, and here's the crux of it: "New Case of PML Confirmed in U.S. A new case of PML, or progressive multifocal leukoencephalopathy, has been confirmed in the U.S., in a patient receiving Tysabri for the treatment of MS. After 14 treatments, the patient reported a change in health status, and the patient’s physician began testing for PML.

If I read what you read, this is news that was reported a month ago, but FDA is only now responding. It involves only one patient so far, and that patient is still alive. Despite ahving not used tysabri, they had used an interferon just before Gilenya, and steroids both before and during the Gilenya treatme t. Worth keeping an eye on this story, for sure.

This release last week announced that Tysabri is now in Phase 3 studies for use in treating SPMS. That has to be good news for anyone following the ASCEND trial. You can read the details at - http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1653040#.TyFoJl4mTgY.

The Peripheral and Central Nervous System Drugs Advisory Committee has recommended that the FDA approve alemtuzumab for the treatment of MS. As with any of our favorite concoctions there are serious risks, but the reduction in relapse rate seems to outweigh them. http://www.medpagetoday.com/Neurology/MultipleSclerosis/42899?

• Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the U.S. FDA and the company have released data suggesting that the risk increases with increasing time on therapy. • The company changed the label of Tysabri to indicate that the risk of PML is increased in patients who have been treated with an immunosuppressant (such as mitoxantrone, and less commonly, azathioprine and methotrexate) prior to receiving Tysabri.

THe FDA failed to approve Lemtrada for sale in the U.S. The FDA said that Sanofi (Genzyme) did not provide sufficient data to prove that the benefits outweighed the risks. Lemtrada is a monoclonal antibody, similar to Tysabri and Rituxan. Like Rituxan it is administered via annual infusion. Lemtrada is approved for sale in the European Union, Australia and Canada. http://www.businessweek.

After being withdrawn from the market, Tysabri was brought back under the TOUCH program (which is strictly controlled by the FDA), and the thought was that if Tysabri was used as a monotherapy, the risk for PML would not be as significant. Unfortunately, this proved not to be the case. At the end of July 2008, it was revealed that there were 2 new cases of PML in Europe - in people who were on Tysabri as their only treatment.

You might also bounce this off of the Biogen team, who would refer you to the FDA if it were deemed a Tysabri side effect, they watch this drug pretty close. I've never come across anyone with MS having a "fiery" feeling.

all the trial patients), and review all of the Safety Data so that they could resubmit Tysabri to the FDA for approval once again (Tysabri is only the second drug to be reapproved by the FDA). I was one of the MS patients that spoke before the FDA AC (via videotape) in March 2006 in an effort to bring Tysabri back to the market. I'm so very grateful that we all succeeded!

Friday I called my neuro to find out if they want me to do a washout period on Tysabri, as they are considering me for the new drug out in March. I've ben on Tysabri almost a year and JC+ from the start The nurse told me my test showed 1.03. which means nothing to me. Anyone know anything about this test?

I'm just curious .... For any of you who are on Tysabri, I was wondering if your neuros had changed their treatment plans or recommendations because of all the new PML cases and the acknowledgement by Biogen and the FDA that risk goes up after 24 months. I hear some are now pulling their patients at 18 or 24 months. I saw my neuro yesterday, and we discussed it in detail .... we are staying the course at this point, which made me very happy. (I go for #18 in a couple of weeks.

Plasmorephis, blood filtering is already standard treatment to get Tysabri out of the body quickly if PML happens. I saw that a trial had been registered with the US FDA in clinicaltrials.gov when Tysabri was returned to market a trial was registered for Plasmorephis blood filtering to remove Trysabri from the body quickly whren it needed to be removed quickly. I was proud of myself for noticing when that trial was registed with the gov & watched it's successful completion.

all the trial patients), and review all of the Safety Data so that they could resubmit Tysabri to the FDA for approval once again (Tysabri is only the second drug to be reapproved by the FDA). I was one of the MS patients that spoke before the FDA AC (via videotape) in March 2006 in an effort to bring Tysabri back to the market. I'm so very grateful that we all succeeded!

Over the last 12 years he has been on all the ABC drugs. Now he is completing the 2 year mark of using Tysabri. Dr Appointment in 2 weeks assume he will stop infusions. I wonder what is next???? How are others doing after all these treatment and now what do they take???

Neurologist do not like to put you in [the PPMS category] because there are no FDA approved treatments for PPMS. Insurance companies do not have to pay for DMDs since they are not FDA approved." ~ "PPMS - how were you diagnosed?" http://www.medhelp.org/posts/Multiple-Sclerosis/PPMS---how-were-you-diagnosed/show/1235216 This is a good point, which I did not realize.

I would like some information/details from anyone who has had (or seen) the rash you can get from Tysabril and/or PML?? I have been on Tysabri 10 years so far without any major issues. I was outside after my treatment for 10 minutes or so. After taking my shirt off, my husband gasped and asked what was wrong with my back.

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tysabri