FDA

Benlysta autoinjector OK’d for children with lupus nephritis

June 30, 2025

FDA approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for SC injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy.

According to a manufacturer press release, the approval represents a “first-of-its-kind subcutaneous option that can be administered at home.”

Note: The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus in 2024.

The most common adverse reactions (≥5%) associated with SC administration of Benlysta include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions.

Sources:

Benlysta (belimumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125370s085lbl.pdf Revised June 2025. Accessed June 27, 2025.

FDA approves Benlysta (belimumab) autoinjector for children with active lupus nephritis. [News release]. 2025. https://us.gsk.com/en-us/media/press-releases/fda-approves-benlysta-belimumab-autoinjector-for-children-with-active-lupus-nephritis/