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GlaxoSmithKline wins Benlysta US label expansion for children

April 30, 2019 / Anna Smith

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).