Novo medicamento para tratamento da hepatite C é aprovado pela Anvisa

Publicado 31/03/2015

Sovaldi (sofosbuvir) é o novo medicamento para o tratamento da Hepatite C registrado pela Anvisa em 2015. A substância passa a integrar a lista de medicamentos inovadores – também composta pelo Daklinza (daclatasvir) e Olysio (simeprevir) – que tiveram processos de análise de registros priorizados pela Agência a pedido do Ministério da Saúde em setembro de 2014.

O medicamento Sovaldi foi aprovado pela Anvisa na forma farmacêutica comprimido e concentração de 400mg. A administração deve ser feita por via oral em adultos, uma vez por dia, sempre de acordo com a recomendação médica.

O pedido de priorização foi realizado dentro dos critérios estabelecidos pela Resolução da Diretoria Colegiada (RDC) 37/2014, que disciplina o tema. A priorização de análise torna mais ágil o processo de registro dos medicamentos pela Anvisa. Apesar da maior agilidade no processo, todas as etapas para o registro de um medicamento no país são mantidas como: análise da tecnologia farmacêutica, de eficácia e de segurança.

O tempo de análise transcorrido após a priorização dos pedidos de registros dos medicamentos Daklinza (daclatasvir) foi entorno de quatro meses, do Olysio (simeprevir) foi de cinco meses. Já o prazo para o registro do Sovaldi (sofosbuvir) levou cerca de 6 meses. Isso atesta a prioridade dada pela Agência para a avaliação de medicamentos de interesse público, já que as novas terapias são tecnologia inovadoras que possibilitarão benefícios aos pacientes com diagnóstico de Hepatite C. Também está sob a avaliação prioritária da Anvisa uma associação medicamentosa de cinco fármacos (dasabovir + ombitasvir + ritonavir + veruprevir + sofosbuvir) para o tratamento da hepatite C. O processo está, no momento, aguardando cumprimento de exigências por parte da empresa.

Fonte: Anvisa

Foto: Agência EBC



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