FDA Approves Belimumab for Children with Active Lupus Nephritis

Belimumab (Benlysta) the first FDA-approved therapy for pediatric lupus nephritis.

The FDA has approved belimumab (Benlysta; GlaxoSmithKline [GSK]) for patients 5 to 17 years of age with active lupus nephritis (LN) who are undergoing standard therapy. The action marks the first FDA-approved therapy for pediatric LN, which can lead to increased complications, hospitalizations, and higher mortality rates in this patient population.

Before the approval, therapeutic options for children were primarily limited to non-selective immunosuppressants and corticosteroids, according to GSK.

“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, VP, Specialty and Pipeline US Medical Affairs, GSK, in a press release. “This Benlysta 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.” 

A BLyS-specific inhibitor, belimumab is a human monoclonal antibody that attaches to soluble BLyS but does not directly bind B cells. By attaching to BLyS, the drug inhibits the survival of B cells, including autoreactive B cells, and decreases the differentiation of B cells into immunoglobulin-producing plasma cells.

Belimumab was initially approved for adult patients with systemic lupus erythematosus (SLE) in 2011. In 2019, belimumab was approved as intravenous (IV) infusion for the treatment of patients aged ≥5 with SLE, which marked the first time that the FDA has approved a treatment for pediatric patients with SLE.

Belimumab is the first and only FDA-approved biologic for both SLE and LN in more than 50 years.

“Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus diagnosis,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America, in a press release. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”

LN is a serious inflammation of the kidneys that is caused by lupus, which can subsequently lead to end-stage kidney disease, which requires treatment with dialysis or a kidney transplant. The latest approval of belimumab extends the current indication in the United States to include lupus and active LN for the IV formulation in pediatric patients.

SLE is the most common form of the disease, and is a chronic, incurable, autoimmune condition linked to a range of symptoms that can change over time, such as painful or swollen joints, extreme fatigue, unexplained fever, skin rashes, and organ damage.

In clinical trials for SLE, the most common adverse effects included nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions. Health care professionals are advised to pre-treat patients with an antihistamine.

Belimumab includes a warning for mortality, serious infections, hypersensitivity, and depression based on data from the clinical studies in adults with SLE. The drug should not be administered with live vaccines.


GSK announces US FDA approval of Benlysta (belimumab) for pediatric patients with active lupus nephritis. GSK. News release. 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/

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