Benlysta was previously approved in the US to treat active lupus nephritis in adult patients, and the current approval expands its indication to include both lupus and active LN in the paediatric patient population
GlaxoSmithKline (GSK) has received the US Food and Drug Administration (FDA) approval for Benlysta (belimumab) to treat active lupus nephritis (LN) in children aged five to 17 years.
Benlysta is a human monoclonal antibody that binds to soluble BLyS to inhibit the B cells, including autoreactive B cells, and reduces the differentiation of B cells into plasma cells.
In December 2020, the drug was approved by the US FDA, as the first medicine to treat active lupus nephritis in adult patients.
The current approval expands the Benlysta indication to include both lupus and active LN for the intravenous formulation in the paediatric patient population in the US.
The drug is not advised in patients with severe active central nervous system lupus.
GSK US medical affairs speciality and pipeline VP Herson Quinones said: “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.
“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.”
The British drugmaker claimed that its Benlysta is the first FDA-approved treatment for LN in children which causes increased complications, hospitalisations and mortality rates.
It is currently conducting research activities to prevent organ and kidney damage in adults and children living with lupus and active LN, said GSK.
LN is a serious inflammation of the kidneys caused by Systemic lupus erythematosus (SLE), which may lead to end-stage kidney disease, requiring dialysis or a kidney transplant.
SLE is a chronic, incurable, autoimmune disease, with a range of symptoms including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.
In LN, SLE causes kidney inflammation of the small blood vessels that filter wastes in the kidney and the kidneys in some cases.
Lupus Foundation of America president and CEO Stevan W Gibson said: “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.
“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”