GSK says FDA approves Benlysta Autoinjector for kids with active lupus nephritis

GSK (GSK) plc announced that the U.S. Food and Drug Administration has approved a 200 mg/mL autoinjector of Benlysta, a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis who are receiving standard therapy. “With this approval, 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. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus in 2024,” the company stated.