Biogen has announced acceptance of marketing applications of Plegridy(peginterferon beta-1a) for review by the US and EU regulatory authorities.
Plegridy, a member of the interferon class of treatments, is a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS).
Interferon beta-1a is pegylated in Plegridy to extend its half-life and prolong exposure in the body.
Biogen Idec research and development executive vice president Douglas Williams said that interferons will remain an important and extensively used option for MS patients.
"At one-year, PLEGRIDY demonstrated significant reductions in relapses and disability progression, as well as a robust impact on several MRI endpoints," Williams added.
"PLEGRIDY, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment."
FDA accepted biologics license application for marketing approval of Plegridy in the US and the European Medicines Agency validated marketing authorisation application of the product.
Positive one-year results from the two-year global Phase III ADVANCE study were included in the applications.
