GSK obtains FDA approval for new indication for Benlysta

The Food and Drug Administration has approved GSK’s Benlysta (belimumab) for the treatment of children aged five to 17 years with active lupus nephritis and 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 U.S. to include both lupus and active LN for the intravenous formulation in the pediatric patient population.

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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, GSK noted.

“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,” said Stevan Gibson, president and CEO of the 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.”

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“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,” said Herson Quinones, vice president of specialty and pipeline U.S. medical affairs at GSK. “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.”