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Biogen Idec Inc Submits Application To FDA For Approval Of Plegridy (Peginterferon Beta-1A) In Multiple Sclerosis


Tuesday, 21 May 2013 04:30am EDT 

Biogen Idec Inc announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY (peginterferon beta-1a), the Company`s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). This regulatory submission was based on the results from the first year of 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. In addition to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for PLEGRIDY to the European Medicines Agency (EMA) in the coming weeks. The Company anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months. 

Company Quote

360.67
6.97 +1.97%
19 Dec 2014