Green light in Europe follows two days after Canadian approval and four months after FDA sanction.
The European Commission cleared Human Genome Sciences (HGS) and GlaxoSmithKline’s (GSK) systemic lupus erythematosus therapy, Benlysta® (belimumab). Approval covers use of the drug as add-on therapy for adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) and a high degree of disease activity who are already on standard therapy. FDA approved Benlysta in March, and the Canadian regulatory agency granted marketing approval for the antibody two days ago. Benlysta regulatory applications are currently under review in additional territories including Australia, Switzerland, Russia, Brazil, the Phillippines, Israel, Singapore, Taiwan, and Colombia.
HGS and GSK have developed Benlysta under a codevelopment and co-commercialization deal signed in 2006. HGS has been responsible for conducting Phase III trials with support from GSK, but the firms have equally shared in Phase III/IV development costs and will equally split sales and marketing expenses, as well as sales profits.
Benlysta is a human monoclonal antibody designed to block binding of the B-cell survival factor BLyS to its receptors on B cells. HGS says that blocking receptor binding inhibits the survival of B cells, including autoreactive B cells, and reduces B-cell differentiation into immunoglobulin-producing plasma cells. HGS discovered the BLyS protein in 1996, and the Benlysta antibody itself was generated by the firm in collaboration with Cambridge Antibody Technology.