Belimumab Autoinjector Receives FDA Approval for Children With Active Lupus Nephritis

The FDA approved an autoinjector of belimumab (Benlysta; GSK) for the subcutaneous injection in children aged 5 years and older with active lupus nephritis (LN) who are receiving standard therapy. This 200 mg/mL autoinjector was also approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024, according to a news release from GSK.^1,2

Doctor writing lupus in black marker | Image credit: MP Studio - stock.adobe.com

SLE is a chronic, incurable autoimmune disease characterized by a range of symptoms—such as painful or swollen joints, extreme fatigue, unexplained fever, skin rashes, and organ damage—that may fluctuate over time. It is the most common form of lupus. LN is a complication of SLE that occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and potential organ damage. Additionally, this inflammation may harm the kidneys’ abilities to remove waste within the blood. Manifestations of LN include proteinuria, elevations in serum creatinine, and the presence of red and white blood cells in the urine.¹

If poorly managed or not treated properly, LN can lead to end-stage kidney disease or LN-related chronic kidney disease (CKD). Of note, a previous review found that approximately 10% to 50% of patients with LN and SLE also have CKD. Earlier stages of the disease are often not detectable or are characterized by few signs and symptoms; therefore, patients do not realize that they have CKD or are not diagnosed until the condition has advanced. CKD can progress to end-stage kidney failure, which is fatal without dialysis or a kidney transplant. CKD shares similar characteristics to those of LN. Although there have been improvements in both diagnosis and treatment of LN, it remains an indicator of poor prognosis for people with lupus.^1,3,4

Belimumab is a B-lymphocyte stimulator (BlyS)-specific inhibitor that binds to soluble BlyS. By doing so, belimumab prevents the survival of B cells—including autoreactive B cells—and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.¹

The most common serious adverse events (AEs) in clinical trials that enrolled adults with SLE were serious infections, some of which were fatal. Additionally, other common AEs were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions as a result of the subcutaneous injection.

“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. Having the [belimumab] 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,” Louise Vetter, president and CEO of the Lupus Foundation of America, said in a news release.¹

With this approval, belimumab is now accessible for patients and their caregivers at home, rather than needing to travel to a hospital or clinic to receive treatment. Prior to the autoinjector’s approval in LN and SLE, the drug was available intravenously administered by health care professionals. This formulation was administered in a clinical setting every 4 weeks for about an hour.^1,2

“For children and parents of children with LN, this approval represents a choice in their care. Providing this at-home treatment option with the efficacy and safety of [belimumab] is a testament to our ongoing commitment to the lupus community…" Court Horncastle, senior vice president and head of US Specialty at GSK, said in the news release. "... our therapeutic solutions should always prioritize improving patients' well-being and easing their treatment journey, including for younger patients."¹

REFERENCES

1. GSK. FDA approves Benlysta (belimumab) Autoinjector for children with active lupus nephritis. News release. June 24, 2025. Accessed June 24, 2025. https://us.gsk.com/en-us/media/press-releases/fda-approves-benlysta-belimumab-autoinjector-for-children-with-active-lupus-nephritis/

2. Gallagher A. FDA Approves Subcutaneous Belimumab for Patients Aged 5 With Systemic Lupus Erythematosus. Pharmacy Times. May 20, 2024. Accessed June 24, 2025. https://www.pharmacytimes.com/view/fda-approves-belimumab-for-patients-aged-5-with-systemic-lupus-erythematosus

3. McGovern G. Prevalence of CKD in Patients With LN and SLE Ranges From 10% to Almost 50%, Review Finds. Pharmacy Times. February 4, 2025. Accessed June 24, 2025. https://www.pharmacytimes.com/view/prevalence-of-ckd-in-patients-with-ln-and-sle-ranges-from-10-to-almost-50-review-finds

4. Mayo Clinic. Chronic kidney disease. Accessed June 24, 2025. https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521