The approval for Benlysta was granted as an additional therapy for the adult patients suffering from active autoantibody-positive systemic lupus erythematosus (SLE) with high degree of disease activity.
Benlysta is under development by GSK and HGS as per a co-development deal signed between the companies in 2006.
GSK European Medical Affairs senior VP Tony Hoos said the European approval of Benlysta represents a significant milestone, and they are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease.