The Food and Drug Administration (FDA) has expanded the approval of Benlysta (belimumab) to include pediatric patients 5 to 17 years of age with active lupus nephritis who are receiving standard therapy. Benlysta, a B-lymphocyte stimulator (BLyS)-specific inhibitor, is also indicated for the treatment of patients 5 years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy.
The approval of Benlysta in pediatric patients with lupus nephritis was based on the extrapolation of efficacy from the intravenous (IV) study in adults with active lupus nephritis, and supported by pharmacokinetic data from IV studies in adults with active lupus nephritis and from pediatric patients with SLE. The estimated Benlysta exposures for pediatric patients were comparable to adults with active lupus nephritis.
The most common adverse reactions associated with Benlysta include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.
Benlysta is supplied as 120mg and 400mg of belimumab in 5mL and 20mL single-dose vials, respectively, for intravenous use. The product is also available in a single-dose prefilled autoinjector or syringe containing 200mg/mL of belimumab for subcutaneous use.
Benlysta may be administered as an IV infusion in patients aged 5 years and older or as a subcutaneous injection in patients aged 18 years and older.
- GSK announces US FDA approval of Benlysta (belimumab) for pediatric patients with active lupus nephritis. News release. GlaxoSmithKline plc. Accessed July 27, 2022. https://us.gsk.com/en-us/media/press-releases/gsk-announces-us-fda-approval-of-benlysta-belimumab-for-pediatric-patients-with-active-lupus-nephritis/
- Benlysta. Package insert. GlaxoSmithKline; 2022. Accessed July 27, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF