Biogen Idec's marketing applications for MS drug Plegridy accepted for review in USA and EU

US biotech firm Biogen Idec (Nasdaq: BIIB) says that its marketing applications for Plegridy (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS), have been accepted for review in the USA and European Union.

The US Food and Drug Administration has accepted the company’s Biologics License Application (BLA) for marketing approval of the drug in the USA and granted it a standard review time. The Marketing Authorization Application was also validated by the European Medicines Agency.

The company said the regulatory applications included one-year results from the two-year global Phase III ADVANCE study ( The Pharma Letter March 20). 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.