Breaking News: FDA Approves Benlysta for Children with Lupus Nephritis

The U.S. Food and Drug Administration (FDA) has approved the drug Benlysta (belimumab) for the treatment of lupus nephritis (LN) in children and teens aged 5 to 17 who are receiving standard therapy. Benlysta is a human monoclonal antibody that was first approved in 2011 as a treatment for adults with lupus, and was approved to treat lupus nephritis in adults in 2020. It is now the first and only approved biologic for both lupus and LN for adults and children.

This is the first FDA-approved treatment for pediatric LN. Before this approval treatment options were limited to less tolerable medications including corticosteroids, antimalarials, and immunosuppressants (a type of drug that lowers the body’s ability to mount an immune response)). These medicines were developed for other diseases, and often have serious and debilitating side effects in children and teens. As a result, many struggled to follow their medication treatment plans.

LN is a common and serious complication of lupus that causes kidney inflammation and can lead to end-stage kidney disease. The approval represents a major advancement for treating LN earlier in life and helping prevent damage at a young age.

Between 15 and 20 percent of all cases of lupus develop during childhood. The symptoms of childhood lupus are more intense, and the long-term organ damage can be more severe. Recognizing these challenges, the Lupus Foundation of America established the first and only national childhood lupus research program, The Michael Jon Barlin Pediatric Lupus Research Program. The program supports discoveries in childhood lupus research and has funded important studies to develop better ways to treat and manage lupus in children and teens.

Continue to follow the Lupus Foundation of America for breaking lupus treatment news. Learn more about caring for children and teens with lupus.

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