The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab; GlaxoSmithKline) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
The approval was based on data from the PLUTO study which evaluated Benlysta IV plus standard therapy in 93 pediatric patients with SLE. The primary outcome measure of the study was SLE responder index 4 (SRI4) response rate at Week 52.
Results showed that more patients treated with Benlysta IV plus standard therapy achieved SRI4 compared with those who received placebo plus standard therapy (52.8% vs 43.6%, respectively). In addition, severe flares were observed to be less frequent in patients treated with Benlysta IV compared with placebo (hazard ratio 0.38; 95% CI 0.18, 0.82); the time until a severe flare was also longer with Benlysta IV (160 days) vs placebo (82 days). Adverse reactions in pediatric patients receiving Benlysta IV were consistent with those observed in adults.
Commenting on the approval, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said, “The agency expedited the review and approval of this application because Benlysta IV fulfills an unmet need for therapies, specifically in pediatric patients with SLE.”
Benlysta, a B-lymphocyte stimulator (BLyS)-specific inhibitor, was previously approved for the treatment of adult patients with active, autoantibody-positive, SLE who are receiving standard therapy. The treatment is available for IV and subcutaneous (SC) administration, however the SC formulation is only approved for use in adults.
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