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