OK, so some news posted in the past few days that is of interest to those of us on Tysabri:
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
http://www.fda.gov/NewsEvents/Newsro.../ucm288471.htm
Biogen and Elan win FDA Approval of label change for Tysabri
http://www.businessweek.com/news/201...r-tysabri.html
and a summary of Biogen's PML monthly update:
As of January 4, 2012, there have been 201 PML cases, of which 116 have been in the European Economic Area, 75 in the US and 10 in rest of world.
As of January 4, 2012, 42 of the 201 patients with PML have died.
As of January 4, 2012, in 47 natalizumab-treated MS patients who developed PML and in whom serum samples were available 6.5-187 months prior to the onset of PML, all 47 patients had anti-JCV antibodies detected.
As of January 4, 2012, samples were available from 74 patients at the time of PML diagnosis and all 74 tested positive for anti-JCV antibodies.
In addition, one sample, collected from a patient at the time of PML diagnosis following a cycle of plasma exchange tested negative for anti-JCV antibodies.
Because this sample was collected immediately following plasma exchange, and plasma exchange removes antibodies from the circulation, the information obtained from this sample is unreliable.
**One patient tested anti-JCV antibody positive two months before PML diagnosis. Previously, the patient had tested anti-JCV antibody negative 15 months prior to PML diagnosis, indicating that they had been exposed to the JC virus at some point between the two tests.
(** means even with a negative Stratify test, you should remain vigilant for any changes in affect, thinking, vision, weakness on one side or the other, etc. If you are unsure of the signs and symptoms of PML, please discuss them with your neurologist so you know what to look for. It is not known how people are exposed to the JC virus, and until they figure out how we are exposed, it remains a risk.)