FDA approves rituximab for rare pediatric vasculitides
medwireNews: The US FDA has expanded the indication for rituximab to include granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children aged 2 years and older.
Rituximab “provides a treatment option that has not existed until now for children who suffer from these diseases,” said the FDA’s Nikolay Nikolov in a press release, noting that the drug “was approved under a priority review, and with orphan designation, to fulfil an unmet medical need for these rare and serious diseases.”
The approval was based on the results of a single-arm clinical trial involving 25 children and adolescents with active GPA and MPA, which demonstrated that the safety profile of rituximab was similar to that in adult patients with autoimmune diseases.
Rituximab is administered as an intravenous injection, and the prescribing information includes a boxed warning for fatal infusion reactions, tumor lysis syndrome, severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy.
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