With the FDA advisory committee meeting mere days away, the activity around Tysabri has become frenetic. In addition to the abstracts we posted yesterday (that will be discussed at the American Academy of Neurologists annual meeting in April), the vaunted New England Journal of Medicine just published 4 more abstracts detailing the final outcomes of the Tysabri clinical trials, as well as the PML safety follow-up.
We will provide a deeper analysis soon, but for now we wanted to get you the links to these critical new abstracts as soon as possible.
In short, Tysabri continued to demonstrate strong efficacy in terms of disability progression and relapses, a relatively low side effect profile, and (hold your breath)-- a risk of PML that has been preliminarily quantified as approximately 1 in 1000, when a person is given nearly 18 months of exposure to Tysabri. This data is of course artificially limited due to the clinical trials being halted last year; the true number can only be known in time.
Click "read more" for the links to the NEJM abstracts.
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Links to NEJM Abstracts on Tysabri
Natalizumab for Relapsing Multiple Sclerosis
Natalizumab in Combination with Interferon for Relapsing Multiple Sclerosis
Evaluation of Patients Treated with Natalizumab for PML
Introductory Editorial (cuts off after 100 words)
