GSK gets USFDA nod for Benlysta for children with active lupus nephritis
London: GSK plc has announced that the US Food and Drug Administration (USFDA) 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. 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.
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.
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