GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis

  • Benlysta is now the first and only biologic approved for adults and children who have lupus or lupus nephritis

LONDON, UK I Jul 27, 2022 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant.i The approval extends the current indication in the US to include both lupus and active LN for the intravenous formulation in the pediatric patient population.

Please see US Prescribing Information for Benlysta.

This is the first FDA-approved treatment for pediatric LN, which remains a driving factor in increased complications, hospitalizations and mortality rates in childrenii. Prior to this, treatment options for children were mainly limited to use of non-selective immunosuppressants and corticosteroids.

“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. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”

“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. “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.”

Through ongoing research, GSK is committed to improving the lives of those living with lupus and researching ways to prevent organ and kidney damage in adults and children living with lupus and active LN.

About lupus nephritis (LN)

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation (swelling or scarring) of the small blood vessels that filter wastes in your kidney (glomeruli) and sometimes the kidneys, by attacking them like they would attack a disease.ii

LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.iii,iv Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.

About BENLYSTA (belimumab)

BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.

The following information is based on the US Prescribing Information for BENLYSTA in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for BENLYSTA.


BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

i National Institute of Diabetes and Digestive and Kidney Diseases. Lupus and Kidney Disease (Lupus Nephritis). Available at
ii Ardoin, S.P., Daly, R., Merzoug, L. et al. Research priorities in childhood-onset lupus: results of a multidisciplinary prioritization exercise. Pediatr Rheumatol 2019; 17, 32.
iii National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis). Available at
iv Gordon C, Hayne D, Pusey C, et al. European Consensus Statement on the Terminology used in the Management of Lupus Glomerulonephritis. Lupus 2009;18:257-26.
v Waldman M and Appel GB. Update of the Treatment of Lupus Nephritis. Kidney International 2006;70:1403-1412.

SOURCE: GlaxoSmithKline

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