Human Genome Sciences (HGS) announced that it has submitted a Biologics License Application (BLA) to the FDA for Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE). The BLA submission includes the results of two pivotal Phase 3 clinical trials, known as BLISS-52 and BLISS-76. These studies show that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.
Belimumab is a human monoclonal antibody drug, being co-developed by HGS and GlaxoSmithKline, which specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein that is 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.