Belimumab for children with lupus in US

July 5, 2019 0 By FM

GSK announced that the US FDA has approved, under priority review, the use of the intravenous formulation of belimumab (Benlysta), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

The approval extends the current indication in the US for the IV formulation of belimumab in adults, to patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

Belimumab was approved in the US in March 2011 for adults and is currently the only medicine specifically approved in the US for both adults and children with SLE. The IV formulation of belimumab is currently not approved for use in children anywhere else in the world.

The approval was based on data from a post-approval commitment study (the ‘PLUTO’ study), assessing the efficacy, safety and pharmacokinetics of 10 mg/kg intravenous belimumab plus standard therapy compared with placebo plus standard therapy for one-year in children aged 5 – 11 years and 12 – 17 years with SLE.

The proportion of children achieving a clinically meaningful improvement in disease activity, as assessed by the SLE responder index (SRI) response rate, was numerically higher in patients receiving belimumab plus standard therapy (52.8%) compared with placebo plus standard therapy (43.6%) at Week 52.