First New Lupus Drug in a Half-Century Approved

The FDA has approved belimumab (Benlysta) to treat patients with systemic lupus erythematosus who are already receiving standard treatment. Belimumab, a fully human monoclonal antibody that targets the B-lymphocyte stimulator protein, is the first new lupus therapy in over 50 years.
In two trials comprising some 1700 patients with lupus, those treated with belimumab plus standard therapy had less disease activity than patients who receive placebo plus standard therapy. The belimumab group may have had fewer severe flares, but the studies were not conclusive. Patients taking belimumab had a higher rate of death and serious infection than the placebo group.
In these studies, the treatment did not seem effective in people of African or African American heritage, but the study populations weren’t large enough to make definitive conclusions. The FDA has asked the manufacturer to undertake another trial in this subgroup.