BLA Submitted For Potential Multiple Sclerosis Therapy
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.
For more information call (617) 679-2000 or visit www.biogenidec.com.