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First Lupus Treatment for Pediatric Patients Approved by FDA

April 26, 2019

The FDA has approved Benlysta (belimumab) intravenous (IV) infusion for the treatment of children with systemic lupus erythematosus (SLE). This disease causes inflammation and damage to various body tissues and organs. Importantly, this is the first treatment approved to treat pediatric patients with SLE.  

“The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability.” 

The approval was based on the results of a 52-week study. 93 pediatric patients with SLE received Benlysta IV.  

The proportion of pediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in pediatric patients receiving Benlysta IV plus standard therapy compared to placebo plus standard therapy,” the FDA explained. “Pediatric patients who received Benlysta IV plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 days versus 82 days).” 

The safety profiles of the drug among children were consistent with those of adults with SLE. Notably, based on findings from clinical studies in adults with SLE, the patient and doctor information of the drug includes a warning for mortality, serious infection, hypersensitivity, and depression.

The most commonly reported side effects included nausea, diarrhea, and fever. Patients receiving Benlysta also experienced infusion reactions. Health care professionals are advised to pre-treat patients with an antihistamine.  

This drug has been approved for use in adult patients with SLE since 2011.  

Julie Gould  


The US Food and Drug Administration. FDA approves first treatment for pediatric patients with lupus [press release]. April 26, 2019.

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