GlaxoSmithKline has announced the US Food and Drug Administration expansion of its intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.
The approval, which marks the first medicine in the US approved for children with systemic lupus erythematosus (SLE), was based on data from a post-approval PLUTO commitment study, which assessed the efficacy, safety and pharmacokinetics of 10 mg/kg intravenous doses.
The proportion of children achieving a clinically meaningful improvement in disease activity was higher in patients receiving Benlysta than it was in the control group, at 52.8% compared to 43.6%, in study results first presented at the 2018 American College of Rheumatology (ACR).
The human monoclonal antibody works by binding to the soluble B-lymphocyte stimulator (BLyS), but does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Dr Hal Barron, chief scientific officer and president, R&D, GSK commented, "Children with lupus have had limited options available to help treat their condition. This accelerated decision means children in the US now have an innovative, FDA-approved medicine available to help manage the impact of living with this challenging autoimmune disease."
SLE is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. SLE is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide.