Biogen Idec announced that it has submitted a Biologics License Application (BLA) to the FDA for approval of Plegridy (peginterferon beta-1a), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). Plegridy is a member of the interferon class, which are often used as first-line treatment of MS. It is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule.

The submission was based on results from the first year of a two-year global Phase 3 ADVANCE study. The data showed that Plegridy met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo.

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