Last Updated on December 31, 2023 by The Health Master
GSK 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.
This is the first pediatric LN treatment that the USFDA has approved, and pediatric LN continues to be a major contributor to increased complications, hospitalizations, and mortality rates.
Before this, children’s treatment options mainly consisted of corticosteroids and non-selective immunosuppressants.
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