Skip to main content
main-content
Top

26-09-2019 | Rheumatology | News | Article

approvalsWatch

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.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

Related content

See the research in context now

with trial summaries, expert opinion and congress coverage

Image Credits