Breaking news: FDA approves Benlysta for children with lupus nephritis

The US Food and Drug Administration (FDA) has approved the drug Benlysta (belimumab) for the treatment of lupus nephritis (LN) in children and adolescents aged 5 to 17 years 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 biologic approved for both lupus and for 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, such as corticosteroids, antimalarials, and immunosuppressants (a type of drug that reduces the body’s ability to mount an immune response)). These drugs were developed for other diseases and often have serious and debilitating side effects in children and adolescents. As a result, many struggled to stick to their drug 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 an important advance in treating NL earlier in life and helping to prevent damage at a young age.

Between 15 and 20 percent of all cases of lupus develop during childhood. Symptoms of childhood lupus are more intense and 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 adolescents.

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

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