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FDA approves Benlysta for children with lupus nephritis

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Published:3rd Aug 2022

The FDA has approved the drug Benlysta (belimumab) from GSK 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.

Condition: Lupus Nephritis
Type: drug

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