tysabri pulled from market

A malaria drug in the lab has shown promise at treating PML, the results should also be released by the end of the year. When Tysabri was pulled from the market, in 2005 the PML risk was 1 in 1000. Since it has been returned to market to used as a monotherapy, without Avonnex the risk if PML is 1 in 9000. The oral drugs that are in the pipeline also carry the risk of PML. To me that means there are a lot of $ riding on being able to treat PML when & if it happens.

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.

"Genentech withdrew its psoriasis drug Raptiva from the market yesterday, citing the risk of developing progressive multifocal leukoencephalopathy (PML), a rare, often fatal brain infection. The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA)." http://www.the-scientist.com/templates/trackable/display/blog.jsp?

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!

Talked with Tysabri caseworker this morning and gleamed some more info as follows; You call them or Tysabri in my case and tell them you are interested, they then send a referral notice to your doctor and in about 2 weeks someone calks you from undetermined #, I asked to be notified or gave them leave a msg as u don't answer for numbers I don't know, and they will discuss your insurance info then, etc.

Funny you mention Tysabri the MS Specialist mentioned that he was alarmed the cases of PML had increased since he did his last power point a few months ago from 14 to 23. He kinda hinted it will probably be pulled from the market. Originally they were blaming the PML on avonex and tysabri used in combination. He says he only uses it when nothing else can be used.

” The patient, who was admitted to the hospital on October 24, underwent plasmapheresis to remove Tysabri from their system and was released from the hospital on October 28. The patient is currently under the care of the treating physician." No update yet on how she is doing. I had heard about a case of possible PML here in the US, last week, so I am assuming it is the same woman. Her husband posted about it on a site I found with people on Tysabri.

( I am not thrilled w Tysabri at this point. Was doing really well on it, from Jan 2010 until the summer when I lost my voice for 3 months. Tysabri was D/C then per Neuro. In case that was a side effect. I went back on Tysabri in Dec. My voice is still an issue. Neuro doesn't know still if side effect, and is leaving it up to me if I want to stay on. She would like me to stay on it, as there is no other alternative for me at the moment.

So you said no issues from the Tysabri infusion? That sounds wonderful to me since my list of allergies is up to 7 or 8. Why was the Tysabri chosen over the others, if you don't mind sharing? I almost but just almost, wish my neuro was firmer in his decisions. It took a lot of pushing to get his true feelings because with MS, ANYTHING can happen and after 30 + years in practice nothing in MS surprises him.

the original 3 cases of PML were indeed initially considered to be due to the use of Tysabri in conjunction with other treatments for MS, particularly interferon. 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.

I too had my blood test JCV+ last month. My CSF was still negative. This means that I'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.

Copaxone is one of the disease modifying agents for MS available on the market. The aminoacids that make up Copaxone protect the myelin sheath of the nerves from attacks by T cells. It is well known to slow the progression of the disease and also has fewer flu like side effects seen commonly with other drugs used to treat MS.

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.

The Biogen Idec lunch talk I went to today was very interesting and quite a different approach than the usual tons of slides about Tysabri. It focused on what those numbers in clinical trials really mean. Of course it was directed at explaining why the Avonex number and Tysabri numbers are what they appear to be, but it really got me thinking.

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!

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?

After wasting her first year post diagnosis with the CRAB drugs, her neuro switched my wife to Tysabri. The two factors that dissuade neuros from use of Tysabri are (1) testing JCV+ AND (2) having previously taken strong immuinosuppresent (chemo) drugs. But after 4 years on Tysabri, my wife tested positive for JCV, and yet her neuro suggested that she stay with Tysabri because she has been doing so well with it. She just had her 60th infusion.

Good luck with Tysabri! I'm taking my 11th infusion on Wednesday. The good news, I haven't had any new flairs since I've been on it. I'm taking a "holiday" from Tysabri after this infusion. My neuro says a periodic holiday keeps the incidence of PML lower. I haven't had my JC virus antibody tested. Is this a blood test, or a urine test?

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.......

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.

Hey Lulu, Let me know if your paperwork mentions anything about the recommended washout period if switching from Tysabri to another med - don't just take my word for it, lol. The 12 weeks is just what the article said - not sure if that is what Biogen recommends or what. I remember when I switched from Rebif to Tysabri, it was a 4 week washout, and I had several different things that were starting up or worsening in that time period.

I know the outcry was huge from MSers who were doing well on it when they pulled it off the shelf initially. They have come a long way since then from my understanding with checking for pml and that is very encouraging. Your a fighter G-Gurl and I know you'll not make this decision lightly.

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.

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???

I guess it takes 4 to 6 weeks. Then a follow up and go from there. He recommends Tysabri if sI want to switch right now. However, depending on what he sees on the MRI it may not be a choice but the only recourse. So, any input on Tysabri would be appreciated. I have mostly good days, but too much activity on Sunday made me a slug yesterday! I woke up refreshed this morning and took a short walk. Felt SO good!

Only Tysabri has shown the abilty to cut relapses and lesions by 2/3s. Tysabri is relatively new and is still has some issues. In fact no one knows what it does after 2 years. The more std. MS drugs, which are primarily interferons by the names of Avonex, Rebif and Betaseron cut MS activity by about 1/3. And thats if you have Relapsing Remitting MS. The drugs are all injected. A new drug that is oral "finglomod" is in phase 3 clinical trials.

If you need to switch from Copaxone and you are uncomfortable with the low risks of Gilenya and Tysabri, the others have a good safety profile and side effects that usually can be mitigated.

Tysabri pulled from market

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