tysabri off market

My sister has had about 20 Tysabri infusions. She was pretty disabled from the onset of the MS when she took a bad fall and has not been able to walk without aid since. Her MRIs were not showing any progression of MS since starting the Tysabri for a really long time. Plus, she tells me that she feels much better (more energy) after the Tysabri infusions. She starts to notice that she isn't doing well right before her scheduled infusion. So, something appears to making a difference.

When Tysabri first came on the market after clinical trials, there were 3 deaths from PML and it was pulled from the market. All 3 patients had been on one of the first line DMDs while they were also taking Tysabri. The thought at the time was that if patients took Tysabri alone, PML would not be an issue. Tysabri was re-released to the market, but with strict conditions and monitoring requirements, known as the TOUCH program. Unfortunately, that has not proven to be true.

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. So I knew about it before it made the news.

) Believe it or not, my big fear at this point is that if more problems keep cropping up, the FDA will pull Tysabri off the market - and then what will those of us in my position do? If Tysabri is taken off the table, the only thing left is Novantrone or clinical trials. And if I fail Tysabri, I don't know if I would qualify for very many clinical trials anyway. So it's not bravery at all - it's more of a lack of options and blind optimism, I guess, lol.

This report is from the NASDAQ ******* business site - tracking key issues on the stock market - Biogen's stock fell Friday on heavy trading with the release of this news about their star drug ...... it is astonishing to think they make $1 BILLION dollars a year on this drug. - Lulu 4th UPDATE: EU Reviewing Biogen, Elan's Tysabri; Cites PML (Updates with FDA comments, beginning in the third paragraph.

The drug, which is used mainly to delay the progression of multiple sclerosis, has been on the market since 2006. It originally went on the market in 2005 but was removed due to medical problems that some patients encountered, Bloomgren said. Tysabri is expensive, costing about $40,000 a year. It dampens the immune system, potentially reducing the inflammation that is a major part of multiple sclerosis.

m still OK Tysabri wise speaking. My neuro likes to reevaluate Tysabri use at 24 months. I had infusion # 18 last week. He thinks I would be an excellent candidate for Tecfidera. He said that if DMD'd were ranked from 1-100, in terms of 'power' Tysabri would be 100 and Tecfidera would be 75/80. As my MS seems to be pretty well under control. I may have needed Tysabri to get it under control. but Tecfidera should be able to keep it under control.

There is a serious disease PML related to Tysabri. The medication was taken off the market several years ago due to three people dying of PML- Progressive Multifocal Leukoencephalopathy. 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.

, meaning they feel terrible and begin having many relapses. Well that sure turned me off! Has anyone gone off Tysabri and had these negative effects? Of course the decision keeps getting tougher for me. Today I began a 5 day steroid i infusion treatment to reduce inflammation from my many recent flare ups. While at the infusion center I spoke with a few people who ere there for their monthly Tysabri infusion. They all are having amazing success with it. All told me how much better they feel.

As our MS World turns, and we talk about the not-so-distant future of individualized medicine for MSers, i.e., identification of biomarkers (what may make one med work for us, and perhaps not the other). Short of knowing (because it's going to be awhile) exactly what's prone to work for you, or, the "You Should Take This One" smoking gun jumping straight out of the petri dish in a lab, how did you decide to change?

When I was originally on Tysabri in February 2005 (before they voluntarily remove Tysabri from the market temporarily), just two weeks after my very first infusion, my right drop foot was gone, my limp was gone, my optic neuritis completely cleared up, my slurred speech was gone, and I put my walker away--only using my cane for balance which had not completely returned at that point. I was so excited!

09 and I have since switched to Tysabri. With tysabri, all of my symptoms, (tingling, numbness, and pain) are all but gone. For me, Tysabri was more effective then Copaxone, but if you have MS and are thinking of switching, Tysabri is a very dangerous drug, inform yourself before making the decision.

My neuro would like to see me on Tysabri but I would prefer it to be on the market longer with more studies as to why some get that brain infection (one in one thousand). What I am doing is trying to buy time. I have agreed that if things become worse then I will do it. I have only been under the care of a competent doctor for six months. I know the MS is out of control and I know it is a gamble to wait. I guess my answer to you is...fear...plain and simple.

s as part of JCV/PML detection protocol. I am having a blood test, brain MRI and an LP every 6 months as part of my Tysabri treatment. This article from the Journal of Neurology discusses this protocol. http://www.msrcny.org/sites/default/files/articles/JCVpaper.

There may be a Washout period between Tysabri and Gilenya before he begins this new drug. A recent study showed that people who go off Tysabri will most probably experience a serious relapse in their MS.

The article also says that the patient was started on Gilenya after only being off Tysabri for 6 weeks, when the recommended washout period is actually 12 weeks. There are still alot more questions than answers about this situation - hopefully more specific information will continue to become available, so it can all be put into better perspective. And hopefully this will prove to be an isolated case ... time will tell.

I had forgotten that Plegridy even exists, so I looked it up for more info. Turns out it is made by Biogen Idec, who also make and market Avonex and Tysabri. It is a kind of interferon, and is administered via injection every two weeks. The doses are stepped up, with full levels reached after several weeks.

At 20 months I had converted to JCV + and the Tysabri was no longer working. While on Tysabri I saw no change in my symptoms. As was said, that is no what any DMD is for. I had no ill effects of any kind.

It seems very unusual for people to be prescribed Tysabri right off the bat. I am very confused as to what drug to go on, if any. His first choice for me is Tysabri, followed by Gilenya, followed by Copoxone. I have a Naturopath (who actually has MS) who is vehemently against all of the drugs and questions their efficacy. The neurologist says it's my decision but I feel completely unqualified to make such an important decision.

t want to switch programs until I know. I have just finished my first year on Tysabri and want to consider options for later but they won't give you prices until you have switched.......

Hi Kat - I will get my 11th infusion in about 10 days. I have had no issues of any kind in conjunction with Tysabri. From the follow up MRI's I've had Tysabri seems to be doing the trick. No new lesions or relapses since I started. You will be tested for the JC virus prior to starting.

I was going to hear off nothing but Tysabri! I even doddled with the rebiff prescription for a few days, telling myself that I wouldn't take anything if I had to self inject. Stupid neurologist!!!!! My 30th birthday looms (like a dark clould) and maturity decided to set in this week and see the sense in the advice I was given by the professional I have come to trust.....

As for me, I am waiting to see if they pull it off the market, or make changes to their prescribing information. When I had my second opinion last week, he said that there are more cases of PML than the stated 24 Biogen have released, and this information is only available to Neuros and PCP – great!!!! Me too I am a blubbering mess, trying to get my head around all of this. All I can say is do your research, and do it well.

Lulu, Thanks, but it's really no surprise - I've been running on the assumption I was positive all along, since it's so common. That's why it's not changing our treatment decisions... Shell, Nope - not brave at all. Just realistic and practical, lol. We assume the Tysabri is still helping (unfortunately, nobody has the crystal ball), so we don't want to rock the boat.

Tysabri off market

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