GSK receives US approval for Benlysta intravenous use in children with lupus
The US Food and Drug Administration (FDA) has approved GSK's Benlysta (belimumab) for intravenous use in children aged five years and older with systemic lupus erythematosus (SLE).
London, UK / Philadelphia, USA – GSK plc announced on April 26, 2019, that the US Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab) for children aged five years and older with systemic lupus erythematosus (SLE). The approval extends the existing indication for Benlysta in the US, which previously applied only to adults.
Benlysta is now the only biologic medicine specifically approved for the treatment of SLE in both adults and children in the United States. The drug was first approved for adults in the US in March 2011.
The FDA's approval was based on data from the PLUTO study, which evaluated the efficacy and safety of intravenous belimumab in children aged 5 to 17 years with SLE. The study showed a numerically higher response rate in the belimumab group (52.8%) compared to the placebo group (43.6%) at Week 52.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can be more aggressive in children than in adults. SLE in children is associated with more rapid accrual of damage and higher morbidity compared to adults.