27 July 2022 - - The US Food and Drug Administration has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis who are receiving standard therapy, UK-based biopharma company GSK plc (LSE: GSK) (NYSE: GSK) said.

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.

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 children.

Prior to this, treatment options for children were mainly limited to use of non-selective immunosuppressants and corticosteroids.

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.

Systemic lupus erythematosus, 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, 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.

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.

Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.

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.