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Jun 7, 2011

EU Approves Biogen Idec’s Avonex Intramuscular Autoinjector Product for MS

  • The European regulatory authorities approved Biogen Idec’s single-use intramuscular autoinjector, Avonex PEN, for patients with relapsing multiple sclerosis and those who have had a single demyelinating event. The prefilled, once-a-week Avonex-based product integrates the previously approved Avonex prefilled syringe with a shorter needle.  

    Clearance in the EU was based on data from an open-label Phase IIIb study in which patients previously using the Avonex prefilled syringe were switched to the new Avonex PEN device. The overall success rate for patients using Avonex PEN was 89%, and 94% of patients expressed a preference for the device over the Avonex prefilled syringe.  



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