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FDA approves belimumab for treatment of pediatric lupus nephritis

This decision by the US Food and Drug Administration marks the first approved treatment for pediatric lupus nephritis.

The US Food and Drug Administration (FDA) has approved belimumab (Benlysta; GSK) for the treatment of lupus nephritis in pediatric patients aged 5 to 17 years who are receiving standard therapy. This decision marks the first treatment approved by the FDA for pediatric lupus nephritis.1

This approval expands upon the current US indication to now include both lupus and active lupus nephritis for pediatric patients.

Belimumab is a BLyS-specific inhibitor and human monoclonal antibody. While belimumab does not directly bind B cells, it does bind to soluble BLyS and inhibits the survival of B cells, such as autoreactive B cells. It also reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Belimumab was first approved by the FDA in 2011 and is the first and only FDA-approved biologic for both systemic lupus erythematosus and lupus nephritis in over 50 years.1

“The long-term goal of lupus nephritis management in adults and children is to preserve renal function while minimizing treatment-related toxicities and associated morbidity,” said Herson Quinones, vice president of specialty and pipeline US medical affairs at GSK.

He added, “This [belimumab] approval highlights GSK’s commitment to bring treatment options to children living with lupus nephritis. This is another example of how GSK continues to get ahead of this burdensome disease by focusing on science and being grounded in over a decade of clinical experience.”


GSK announces US FDA approval of Benlysta (Belimumab) for pediatric patients with active lupus nephritis. GSK US. July 27, 2022. Accessed July 28, 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/