tysabri fda approval

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?

This means that even though it has been used successfuly for years, the manufacturer did not submit Rituxan for FDA approval specifically for MS treatment. This can make it diffcult to get insurance coverage, and it's not cheap. Tysabri is FDA approved for MS treatment and insurance coverage is typically easier to get. Last but not least, or maybe least, Tysabri is administered every 4 weeks, with each infusion taking aboiut an hour.

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).

BG-12 was submitted to the FDA for fast track approval, but that still means probably won'tbe on the market until early 2013. I'm so sorry the tysabri is not kicking MS butt for either of you these days.

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.

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.

The FDA must approve or disapprove of telaprevir on or before May 23 of this year. How long it will take to get on the drug formularies is something we do not know yet.

As they have to answer to their stockholders, this medication will never go on to FDA approval, unless someone pours their own funding into it.

Agreed! The names they come up with can be just silly! In any case, I'm hoping this leads to a release sooner than later. I'm happy on Tysabri, and since I'm JC negative (and I get tested regularly) I can take it for a long time. But if that ever changes, Tecfidera will be my next choice!

My insurance finally approved Tysabri!! Both neuros recommended it, but we've had issues getting approval. My new one was willing to fight for me. I have my first infusion Monday morning. My son graduates on Wednesday so I'm hoping all goes well!

I was offered to apply for the study, but I am going to wait for the approval from the FDA.

Thanks for the support girls. It is so hard to judge Dr's thoughts sometimes. I am dying to see the report he sends my neuro. My appt is July 21 but I am on cancelation list. I tried Rebif starting March '09 and due to site reactions switched to Betaseron Dec '09. So I was on interferon for about 16 months. About the DMD pill, fingolimod is the one we discussed.

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????

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint.

You can thank our FDA for this delay. Here is an example of how their drug approval process kills thousands of people each year! http://www.lef.org/magazine/mag2010/nov2010_FDA-Delay-of-One-Drug-Causes-Lost-Life-Years_01.

shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?

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!

BG-12 is an oral drug for MS that has a significantly better efficacy rate than the drugs we have now. It has been submitted to the FDA for approval and it may be on the market early next year.

Biogen appears to have had their ducks in a row for when they got the FDA approval. Go to http://www.tecfidera.com/ for more info, including a link on the right to their patient start form if you want to get on it. No sign of what they're planning to charge insurance companies, but they do have a $10/month co-pay program for patients.

ve been following BG12 and the majority of the mentions of its efficacy and forward path in the FDA approval process does seem to come from the financial advisers who rate stocks as to whether investors should buy, hold or sell. Right now they are all saying either buy or hold with Biogen Idec, because of the promise that BG12 will make lots of money. There may be some new news on BG12 in the ECTRIMS video links I just posted. That would give the medical perspective.

Each drug trial and treatment requires an approval from the FDA, to the best of my knowledge. In that regard, the FDA so far as Vertex may approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well. Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.

Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available. Hang in there!

Tysabri fda approval

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