Benlysta belimumab regulatory update

FDA's Arthritis Advisory Committee voted 13-2 in favor of approving Benlysta belimumab from Human Genome 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.

Panel members largely shrugged off FDA's concerns about infection rates, suicides and potential for increased risk if Benlysta were combined with more potent immunosuppressives than those used in the trials. They said the safety profile demonstrated in the clinical trial program was acceptable for the SLE population and not unexpected for a drug with Benlysta's mechanism. They did note that long-term follow-up in the postmarket setting would be necessary to further characterize the mAb's safety profile. ...