FDA Greenlights At-Home Belimumab Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, the U.S. Food and Drug Administration (FDA) approved a 200 mg/mL autoinjector formulation of belimumab (Benlysta), marking a significant advancement in the treatment options for pediatric lupus nephritis. This approval allows children aged five years and older to administer the biologic therapy at home, facilitating better management of the condition and reducing the need for frequent clinic visits. This decision is particularly impactful considering that lupus nephritis affects approximately 30% to 50% of children diagnosed with systemic lupus erythematosus (SLE), often leading to severe kidney damage if left untreated.

Lupus nephritis is characterized by the immune system's inappropriate attack on the kidneys, which can result in irreversible damage and, in severe cases, end-stage renal disease requiring dialysis or transplantation. According to Louise Vetter, President and CEO of the Lupus Foundation of America, the availability of the autoinjector provides families with much-needed flexibility in managing their treatment schedules.

Belimumab, a B-lymphocyte stimulator-specific inhibitor, was first approved for adult patients with SLE in 2011 and has since been recognized for its efficacy in treating both SLE and lupus nephritis in pediatric populations. The new autoinjector formulation was previously approved in May 2024 for SLE, expanding its indication to include lupus nephritis through this latest FDA decision.

The approval was based on multiple studies demonstrating the drug's safety and efficacy in pediatric cohorts. For instance, a retrospective cohort study published in the *European Journal of Pediatrics* in 2024 highlighted that combining belimumab with standard treatment protocols resulted in comparable renal remission rates to traditional therapies, despite the belimumab group exhibiting higher baseline disease activity (Li et al., 2024). Notably, patients treated with belimumab experienced quicker recovery of complement levels (C3/C4) and required significantly lower glucocorticoid doses over a 12-month period, suggesting potential advantages in reducing long-term steroid exposure without sacrificing treatment effectiveness.

Court Horncastle, Senior Vice President and Head of U.S. Specialty at GSK, emphasized that this approval presents a significant choice for families dealing with the complexities of lupus nephritis. Caregivers will receive comprehensive training on the safe administration of the autoinjector, ensuring that children can receive their treatments effectively and safely at home.

Despite the promising benefits, the prescribing information for belimumab includes warnings for serious infections and hypersensitivity reactions, as well as the risk of depression or suicidality. The most common adverse reactions reported include nausea, injection site reactions, and headaches.

In summary, the FDA's approval of the belimumab autoinjector represents a pivotal moment in pediatric lupus nephritis management, offering families the ability to administer treatment at home, thereby enhancing patient comfort and potentially improving health outcomes. As this new treatment becomes available, ongoing monitoring of its impact on patient quality of life and long-term health will be essential.

**Sources**: 1. FDA approves belimumab (Benlysta) autoinjector for pediatric lupus nephritis. GSK. June 24, 2025. 2. Li H, Chen C, Yang H, Tu J. Efficacy and safety of belimumab combined with the standard regimen in treating children with lupus nephritis. *Eur J Pediatr*. 2024;183(9):3987-3995. 3. Vetter L. Interview on the implications of belimumab approval. Lupus Foundation of America. June 2025.