The United States Food and Drug Administration Advisory Committee voted UNANIMOUSLY (12-0) that Tysabri should be returned to market, on the condition that Biogen/Elan maintain a tracking database on all patients exposed to Tysabri to quickly observe and react to any side effects, particularly that of PML. At this point, there have been no requirements stated in terms of periodic spinal taps or MRIs.

Furthermore, the panel voted 7-5 on whether Tysabri should be considered a "first-line" treatment for MS'ers, which is a somewhat surprising result given the usually conservative nature of a government agency.

"Most people in (Tysabri) studies did not have a relapse and did not have disability progression," panel chairman Dr. Karl Kieburtz was quoted as saying.

The panel continues to meet through the day to discuss further scientific issues related to Tysabri. Of particular interest is being able to discern the early signs of PML versus "normal" MS symptoms, as that will be a critical part of the patient care given by a prescribing neurologist. We will keep you updated as we learn more.

Remember, the FDA is not *required* to follow the recommendations of their panel, but almost always does. Without getting ahead of ourselves, it seems rather certain that for those that want it and are willing to accept a PML risk that has been preliminarily quantified as 1 in 1000 (indeed this number comes from patients exposed to Tysabri *and* Avonex, but the conservative estimate assumes the risk comes from Tysabri), the once-a-month infusion with relatively better patient outcomes than the currently available NCRABs should be available again shortly.

Any day that involves more treatment options being made available to the MS community-- with appropriate risk management-- is a good day for all of us.

Stay tuned... in the meanwhile, links to some source articles are available by clicking "read more".

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Reference Articles

Associated Press
Reuters