Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication.
The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate developed for relapsing forms of multiple sclerosis.
The BLA application included the results from the first year of the two-year Phase 3 ADVANCE study that met all the primary and secondary endpoints.
Plegridy significantly reduced disease activity such as relapses, disability progression and brain lesions compared to placebo, in addition to demonstrating favorable safety and tolerability profiles at one year.
Biogen Idec research and development executive vice president Douglas Williams said the filing demonstrates the company's commitment through the discovery of new medications and development of innovative solutions for treating MS.
A marketing authorisation application for Plegridy is expected to be submitted to the European Medicines Agency in the next few weeks.
