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January 16, 2013
05:23 EDTBIIB, ELNBiogen Idec, Elan submit applications for first-line use of Tysabri
Biogen Idec (BIIB) and Elan Corporation (ELN) announced that they have submitted applications to the FDA and European Medicines Agency, or EMA, requesting updates to the Tysabri labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis, or MS, who have tested negative for antibodies to the JC virus, or JCV. A formal assessment of both applications is ongoing. These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with Tysabri. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider Tysabri early in the course of treatment, regardless of the level of disease activity or prior treatment history. Tysabri is a highly efficacious treatment that has been shown to slow disability progression by 42%-54% and reduce annualized relapse rates by 68%.
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