Biogen Idec (BIIB: Quote) announced Friday that U.S. and EU regulatory authorities have accepted the marketing applications for the review of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis or MS.
The U.S. Food and Drug Administration or FDA has accepted Biogen Idec's Biologics License Application or BLA for marketing approval of Plegridy in the United States and granted the company a standard review timeline. The Marketing Authorisation Application or MAA of Plegridy for review in the European Union was also validated by the European Medicines Agency.
The regulatory applications included positive one-year results from the two-year global Phase 3 Advance study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.
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by RTT Staff Writer
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