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news.Biogen Idec's Avonex has been approved by the US Food and Drug Administration for treating relapsing forms of multiple sclerosis (MS).
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Avonex Pen (Avonex 30mcg/0.5mL solution for injection) is the first single-use, once-a-week, fully integrated intramuscular (IM)autoinjector, designed to be easier to use than currently available Avonex prefilled syringe.
The pen features a protective injector shield that conceals the needle prior to injection, automated needle insertion and medication delivery.
In addition, the injector comprises a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication.
Avonex is indicated to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.
The approval follows the open-label multicenter Phase 3b study, that evaluated the efficacy and safety of Avonex Pen over prefilled syringe.
Avonex injector has been approved in the European Union and Canada in 2011.