HGSI slips after panel backs narrowed Benlysta label

Human Genome Sciences Inc. (NASDAQ:HGSI) fell $1.37 to $24.51 on Wednesday after an FDA advisory committee voted 13-2 in favor of approving Benlysta belimumab to treat systemic lupus erythematosus (SLE). However, panel members who voted yes felt the label should reflect the populations studied in Phase III trials, which excluded patients with severe lupus nephritis or CNS manifestations of the disease. Human Genome had proposed an indication for reducing disease activity in adult patients with active, autoantibody-positive SLE who are receiving standard therapy. ...