EMA gives nod to belimumab for children with lupus
medwireNews: The EMA has recommended that the indication for belimumab should be expanded to include pediatric patients with systemic lupus erythematosus (SLE).
Previously approved as an add-on therapy for adult patients with active autoantibody-positive SLE and high disease activity, the B cell-targeted monoclonal antibody therapy may now be given as add-on therapy for patients aged 5 years and older meeting these criteria.
The European prescribing information for belimumab includes a black triangle label for additional monitoring, meaning that its long-term effects will be monitored more intensively than those of other medicines.
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