Belimumab becomes first FDA-approved drug for pediatric lupus nephritis
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The FDA has approved GlaxoSmithKline’s belimumab for the treatment of children with active lupus nephritis who are also receiving standard therapy, according to a company press release.
The announcement makes belimumab (Benlysta, GlaxoSmithKline) the first FDA-approved treatment for pediatric lupus nephritis, the release said. The new indication includes children aged 5 to 17 years.
“Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first 2 years after their initial lupus diagnosis,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in the release. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”
Previously, belimumab was approved for the treatment of systemic lupus erythematosus in adult and pediatric populations. It later became first therapy authorized to treat adults with lupus nephritis in December 2020.
“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,” Herson Quinones, vice president of specialty and pipeline U.S. medical affairs at GlaxoSmithKline, said in the release. “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.”
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