Biogen files Plegridy at FDA for treatment of relapsing Multiple Sclerosis

Biogen Idec has announced it has submitted a Biologics License Application (BLA) to the FDA for approval of Plegridy (peginterferon beta-1a), the company�s pegylated subcutaneous injectable candidate for relapsing forms of Multiple Sclerosis.

This regulatory submission was based on the results from the first year of the two-year global Phase III 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.