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FDA Approves Benlysta Autoinjector for Treatment of Children with Lupus Nephritis
The U.S. Food & Drug Administration (FDA) has granted approval for a new subcutaneous autoinjector formulation of belimumab (Benlysta®) treatment for children ages five years and older with active lupus nephritis (LN, lupus-related kidney disease) who are receiving standard therapy. The 200 mg/mL subcutaneous autoinjection therapy is a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody which can be administered at home and offers more flexibility and convenience for children and their caregivers. The autoinjector for children with systemic lupus erythematosus was approved in 2024.
Louise Vetter, President and CEO of the Lupus Foundation of America, emphasized the importance of the Benlysta approval, explaining that this new at-home option for medication “provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life."
Lupus nephritis usually leads to greater risks of further complications and long-term organ damage. Continue to follow the Lupus Foundation of America for updates on lupus drug developments. Learn more about Benlysta.
