announcement of JCV antibody test included

[0485c10]

This is the news announcements of biogens submission to get the JCV anti body test included in the product labeling ii both the US FDA and Eurpopes EMA committee.

Their intention to do this had been leaked previously, this is confirmation that the "leak" had some validity.

Also "leaked" is they are finding about 50% positive for the JCV antibody, there is a correlation between greater risk for PML when using Tysabri if the JCV antibody is present, although there is still a risk of PML if the JCV antibody is not present, just a lower risk than if its present,a negative JCV anti body test can "spontaneously change to positive in the future so some type of periodic JCV anti body tests will be required while using Tysabri, the report of the strata trails about this JCV antibody test should be released in January 2011 with every effort to get the blood test to the market and in general use soon after....

Here are links to reports that biogen has officially made a request to get a change to the label to include the JCV antibody test.

http://www.businesswire.com/news/hom...ncement-Biogen

http://www.news-medical.net/news/201...A-and-EMA.aspx

PS I'm over the top excited about this, just looking forward to controversy about Tysabri being resolved.

[batman12]

So do they have the data? When do we get to see that?

[0485c10]

I read in that "unsubstantuated" new article, a few months back, that they plan on releasing the results of the trials in January.

This news of the official requets to update the black box label on Ty, makes it sound like they are on schedule.

My next neuro appointment is in march. By that time I assume she will have read the trial report & the jcv blood test may already be available on the market....

one more thing to cross of my list of things to do.

[Redwings]

So do they have the data? When do we get to see that?

There was some preliminary information published that wasn't identified as the STRATA study, but it might be this: Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303 (http://www.ncbi.nlm.nih.gov/pubmed/20737510). Since this study is completed, it would make sense that final results could be released in January.

For anyone who hasn't been following the research, the STRATIFY-1 and STRATIFY-2 trials are also investigating the JCV antibody in the MS population to determine whether the risk of PML in people who are JCV antibody negative may be lower than in those who are JCV antibody positive. They just started recruiting in the Spring of this year and will run for 2 years. The study group for STRATIFY-2 is expected to be 10 times larger than for STRATA. The larger study group might provide more statistically reliable information. That's important because the findings about the prevalence of the JC virus in general and its activity in people with MS has been all over the spectrum and contradictory.