GSK plc received US Food and Drug Administration (FDA) approval for a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. 

GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. 

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind B cells directly. 

The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024.

Caregivers of children who are currently using intravenous infusions of belimumab to manage their LN can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate.

Court Horncastle, Senior Vice President, and Head of US Specialty, GSK, said, “Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritize improving patients’ well-being and easing their treatment journey, including for younger patients.”