Tysabri ms fda

Common Questions and Answers about Tysabri ms fda

tysabri

Avatar m tn 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.
572651 tn?1530999357 s re-purposing of their chemo drug to be used for MS as Lemtrada, you will be interested to read it appears the FDA had brought that plan to a screeching halt . http://www.businessweek.
Avatar f tn 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.
294425 tn?1288528395 I found it interesting that in making the decision to allow Tysabri back on the market, the FDA acknowledged that people with MS should be allowed the decision to take the risks involved. It wasn't that suddenly Tysabri was found to be safer, but that its availability was needed by people with a nasty disease and few options. I will say that the news about melanoma was news to me. My problem with Novantrone is that it does damage to the heart from the getgo.
572651 tn?1530999357 I fail to understand why this is news when the FDA has already approved it for use in that form of MS and has...well, at least since my dx a year ago.
1831849 tn?1383228392 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?
Avatar f tn They found out the reason people contracted PML was because they were taking Avonex/and the other MS medications with Tysabri. I think the Tysabri has given me a second chance at helping slow my disease progress, but with out it I would be on no MS medications to slow the disease. I did alot of research before I decided to start the medication and the one resource that helped me make my decision was reading the Tysabri diaries on line. www.msrc.co.uk/index.cfm?
1115136 tn?1258778476 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!
1475492 tn?1332884167 Someone said that Jose who died from PML were taking more than one MS medication. Is that more than one DMD or treatment for symptoms?
1831849 tn?1383228392 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.
1831849 tn?1383228392 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.
738075 tn?1330575844 • 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.
1950519 tn?1324518193 Hello, I am a caretaker of my friend who has MS. 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???
645390 tn?1338555377 Aww, Michelle! I'm so sorry Ty isn't doing it for you. I'm hanging in there for when BG 12 comes out as well. It sounds promising. I used to loose my voice during flares, and the muscles around my larynx would be sore and tired any time I tried to use my voice for singing or talking. I feel for you!
572651 tn?1530999357 Design, methodology and baseline features of EMPOWER, the largest randomized, placebo-controlled, Phase 3 clinical trial conducted in patients with ALS to date Additional presentations include long-term data for AVONEX; data highlighting FAMPYRA, the first oral formulation indicated for the improvement of walking in adult MS patients with walking disability; and full data from the DAC HYP Phase 2b SELECT trial.
Avatar f tn I would hate to go back to what I was before tysabri. I am seeing ms specialist dec 31st to see what my options are for dmd. I wont go back to shots and not happy with side effect profile from tec. I was hoping lemtrada would been approved by now as I would try that.
462771 tn?1358355843 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!
294425 tn?1288528395 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.
Avatar f tn 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.
Avatar f tn I saw my neuro on Friday and in the course of a fairly long appointment and discussion, I asked a lot of questions. One in particular had to do with oral meds, which we've been told for years are right around the corner. He says yes, they'll definitely be available very soon, but prescribing them will be difficult because of their side effects. Only select patients will get them. I asked if this included those who couldn't tolerate or just didn't do the injections.
572651 tn?1530999357 Was just looking into this drug last night via MS Ireland's latest newsletter. It actually has European Medicines Agency approval, which it received almost simultaneously with FDA approval. However, as you say, this Reuters piece indicates delays in its actual release in Europe. Though they didn't make it clear what the estimates were based on, the MS Ireland newsletter stated that it should be available for patients in Ireland in late 2014 (c. 18 months).
382218 tn?1341181487 ) This month, the FDA fast-tracked Tovaxin, a drug developed to treat secondary progressive MS on the grounds that no other therapies were available for this group.
1337734 tn?1336234591 Hi, I was diagnosed with MS in 2005. I have been through 4 different treatments including Tysabri and Gilenya. I was on Tysabri for 4 years before I was able to take the JC test in which I was positive for the antibodies, so they have now switched me to Gilenya. I am on the fence at the moment of whether or not to change to a different medication. I have fatigue and or wobbly left leg after I go for a walk.