medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended that the indication for rituximab should be expanded to include granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients.
Previously approved in Europe for a number of conditions including adult GPA and MPA, rheumatoid arthritis, pemphigus vulgaris, and some blood cancers, rituximab may now be used alongside glucocorticoids to induce remission in children aged 2–17 years with severe, active GPA and MPA.
The B cell-targeted agent is administered by intravenous infusion, and the European prescribing information includes a warning about infection risk, including progressive multifocal leukoencephalopathy.
This announcement follows approval of rituximab for pediatric GPA and MPA by the US FDA in 2019.
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