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This excerpt taken from the ELN 20-F filed Mar 30, 2006. FDA
Review of Tysabri for the Treatment of MS
On March 7-8, 2006, the PCNS Advisory Committee reviewed and
voted unanimously to recommend that Tysabri be
reintroduced as a treatment for relapsing forms of MS. On
March 21, 2006, we and Biogen Idec were informed by the FDA
that the agency would extend its regulatory review of
Tysabri by up to 90 days in order to complete a full
review of the Tysabri risk management plan. Under the
revised timeline, we anticipate an action from the FDA about the
reintroduction of Tysabri as a treatment for relapsing
forms of MS on or before June 28, 2006.
In November 2004, the FDA had granted accelerated approval of
Tysabri as a treatment for relapsing forms of MS to
reduce the frequency of clinical relapses, making Tysabri
the first humanized monoclonal antibody to be approved for
the treatment of MS. Revenue from sales of Tysabri
amounted to $11.0 million in 2005
(2004: $6.4 million).
Table of Contents
The PCNS Advisory Committee review regarding Tysabri
culminated a
13-month
process focused on reviewing the safety of the therapy and
encompassing the following events:
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