BRIEF—GSK announces FDA approval of Benlysta for pediatric patients

GSK has announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged five to 17 with active lupus nephritis (LN) who are receiving standard therapy.

The approval extends the current indication in the USA 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, hospitalizations and mortality rates in children. Prior to this, treatment options for children were mainly limited to use of non-selective immunosuppressants and corticosteroids.

“Active LN is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus diagnosis,” said Stevan Gibson, president and chief executive, Lupus Foundation of America. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”