medwireNews: The US FDA has approved intravenous belimumab as the first treatment for pediatric systemic lupus erythematosus (SLE).
The approval of belimumab highlights the collaborative efforts of the pediatric rheumatology community.
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Belimumab has been approved for treating adults with SLE since 2011. The indication has now been expanded to include pediatric patients following the results of a study demonstrating that the addition of belimumab to standard therapy improves SRI response rates and reduces severe flare risk in children with SLE.
“The agency expedited the review and approval of this application because [intravenous belimumab] fulfils an unmet need for therapies, specifically in pediatric patients with SLE,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
“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,” she added.
The prescribing information warns of an increased risk for mortality, serious infections, hypersensitivity, and depression with belimumab, and specifies that the drug should not be given alongside live vaccines.
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