FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

The US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active lupus nephritis (LN) who are receiving standard therapy.1

Initially approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024, the approval of the belimumab autoinjector for LN offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. According to GSK, it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population.1

“In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child's growth and quality of life,” Louise Vetter, President and Chief Executive Officer of the Lupus Foundation of America, said in a statement.1 “Having the Benlysta autoinjector 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."

A B-lymphocyte stimulator specific inhibitor that binds to soluble BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Of note, belimumab does not bind B cells directly. It was approved for the management of LN by the FDA in 2020 based on data from the BLISS-LN trial. With the approval, it became the first agent to be approved by the FDA for both systemic lupus and LN.1,2

With the latest approval, belimumab 200 mg/mL autoinjector is now indicated for patients aged ≥ 5 years of age with active LN who are receiving standard therapy. However, according to GSK, it is not recommended in patients with severe active central nervous system lupus.1

According to a release from GSK, 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. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector, which will be available for pediatric patients and their caregivers immediately.1

“For children and parents of children with lupus nephritis, this approval represents a choice in their care,” said Court Horncastle, Senior Vice President, and Head of US Specialty, GSK.1 “Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community.”

References

1. GlaxoSmithKline. FDA approves Benlysta (belimumab) Autoinjector for children with active lupus nephritis. June 24, 2025. Accessed June 24, 2025. https://www.businesswire.com/news/home/20250623981547/en/FDA-approves-Benlysta-belimumab-Autoinjector-for-children-with-active-lupus-nephritis.

2. GlaxoSmithKline. FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US | GSK. www.gsk.com. Published December 17, 2020. Accessed June 24, 2025. https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-benlysta-as-the-first-medicine-for-adult-patients-with-active-lupus-nephritis-in-the-us/.