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A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou a ampliação do uso do medicamento Stelara® (ustequinumabe) para o tratamento de pacientes pediátricos a partir de 6 anos de idade com colite ulcerativa ativa de moderada a grave.
A colite ulcerativa é uma doença inflamatória intestinal crônica que pode apresentar curso mais agressivo na população pediátrica, frequentemente associada a maior extensão da doença, maior necessidade de hospitalizações, uso de corticosteroides e risco de colectomia. Além disso, a condição tem impacto relevante no crescimento, desenvolvimento e qualidade de vida dos pacientes.
No Brasil, as opções terapêuticas aprovadas para essa população são limitadas e, em sua maioria, são restritas a agentes anti-TNF (inibidores do fator de necrose tumoral), o que evidencia a necessidade médica não atendida.
Confira a Resolução 2.349/2026 no Diário Oficial da União (DOU).