Belimumab autoinjector receives U.S. FDA approval for use in pediatric SLE

On May 20, 2024, the U.S. Food and Drug Administration approved the at-home use of belimumab autoinjector, alongside standard therapy, in patients aged ≥5 years with active systemic lupus erythematosus (SLE).¹

Previously, patients aged ≥5 years could receive belimumab only through intravenous administration by healthcare professionals in clinical settings. This involved a weight-based dose of 10 mg/kg as a 1-hour infusion, every 4 weeks, post an initial loading phase on Days 0, 14, and 28. Now, if healthcare professionals deem at-home administration suitable, patients’ caregivers can administer belimumab 200 mg autoinjector once weekly to patients weighing ≥40 kg or every other week to patients weighing 15 kg to <40 kg.¹