The FDA has approved Benlysta (belimumab for injection; Human Genome Sciences and GlaxoSmithKline) for the treatment of active, autoantibody-positive lupus (systemic lupus erythematosus) in patients receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. This approval was based on data from two clinical studies involving 1,684 patients that demonstrated that patients treated with Benlysta plus standard care experienced less disease activity than those who received placebo plus standard care. Results suggested, but did not definitively establish, that some patients treated with Benlysta had a reduced likelihood of severe flares, and that some reduced their steroid doses.
Belimumab is a human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein required for the survival and maturation of B-lymphocyte cells into plasma B cells. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues.
Benlysta is expected to be available within the next two weeks.