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).
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: