GSK plc has announced that the U.S. Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector form of Benlysta (belimumab) for subcutaneous injection in pediatric patients aged five and older with active lupus nephritis (LN) who are receiving standard therapy. This approval offers children and their caregivers a first-of-its-kind, at-home treatment option for this serious lupus complication.
Lupus nephritis occurs when the immune system attacks the kidneys, leading to inflammation and possible organ damage. Approximately 30-50% of children with lupus develop LN within one to two years of diagnosis. The new autoinjector expands on the 2024 FDA approval of the same dosage form for children with active systemic lupus erythematosus (SLE).
Louise Vetter, CEO of the Lupus Foundation of America, highlighted the significance of this approval: “In children, lupus tends to be more aggressive and severe. Having the Benlysta autoinjector provides a much-needed option that reduces clinic visits and offers greater flexibility for families.”
Court Horncastle, Senior Vice President and Head of US Specialty at GSK, emphasized the company’s commitment to patient-centered care: “This approval represents a choice in care, allowing children with lupus nephritis to receive an effective treatment at home, easing their treatment journey.”
Caregivers of children currently receiving belimumab via intravenous infusion can consult healthcare providers to determine if switching to the autoinjector is appropriate. The autoinjector is available immediately to pediatric patients and their caregivers.