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AbbVie submete à aprovação da ANVISA seu novo tratamento para hepatite C, totalmente oral e livre de Interferon

É o primeiro regime de tratamento totalmente oral e livre de interferon para pacientes do genótipo 1 infectados com vírus de Hepatite C e com eficácia entre 90% a 100% a ser submetido às autoridades sanitárias brasileiras

O dossiê para aprovação baseia-se no maior programa de Fase III já realizado até hoje, com pacientes do genótipo 1 infectados com vírus de Hepatite C, o genótipo mais comum no Brasil e no mundo

O novo regime terapêutico da AbbVie apresentou alta eficácia com resposta virológica sustentada (eliminação do vírus) entre 90% e 100%. Entre o grupo de pacientes cirróticos, difíceis de tratar, em estudo de Fase IIIb, a taxa de resposta virológica (eliminação do vírus) foi de 92%

Este novo regime terapêutico também já foi submetido à aprovação da Food and Drug Administration (FDA) e da Agência Europeia de Medicamentos (EMA). Em ambas, o novo regime terapêutico da AbbVie para Hepatite C recebeu análise prioritária de avaliação.


News provided by

AbbVie Brasil

Aug 28, 2014, 11:45 ET

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SÃO PAULO, 28 de agosto de 2014 /PRNewswire/ -- A AbbVie submeteu a Agência Nacional de Vigilância Sanitária (ANVISA) pedido de aprovação para comercialização para o seu tratamento totalmente oral e sem o uso de interferon, para pacientes adultos com Hepatite C, genótipo 1, o mais prevalente no Brasil e no mundo. O pedido de aprovação do novo regime terapêutico baseia-se nos dados do maior programa clínico desenvolvido até hoje1 com pacientes com Hepatite C crônica, genótipo 1, composto por seis estudos de Fase III que incluíram mais de 2.300 pacientes em mais de 25 países.  

A AbbVie já entrou com pedido de aprovação também na Agência Europeia de Medicamentos (EMA) e  nos Estados Unidos (FDA) – em ambas as agências, o regime de tratamento da AbbVie recebeu análise prioritária para esta submissão.

Nestes seis estudos de  Fase III, o novo regime terapêutico da AbbVie apresentou alta eficácia com resposta virológica sustentada (eliminação do vírus) entre 90% e 100%, conforme a população do estudo e o estágio da doença, em 12 semanas de tratamento.  Entre o grupo de pacientes cirróticos, em estudo de Fase IIIb, a taxa de resposta virológica (eliminação do vírus) foi de 92%, em 12 semanas de tratamento, chegando a 96%, em 24 semanas de tratamento.

O regime  de tratamento da AbbVie para HCV consiste na combinação de três agentes virais de ação direta.  A combinação dos três diferentes mecanismos de ação interrompe o processo de replicação do vírus, otimizando a resposta virológica em pacientes em diferentes estágios  da doença.

"Esta submissão é um passo importante e nos coloca mais próximos à oportunidade de oferecer a pacientes com Hepatite C crônica, genótipo 1, um tratamento totalmente oral, livre de interferon com alto grau de eficácia, que representa um grande avanço para a comunidade de HCV no Brasil", afirma José Eduardo Neves, Diretor Médico da AbbVie no Brasil.

Globalmente, cerca de 160 milhões de pessoas são cronicamente infectadas com Hepatite C e estima-se que  3 milhões a 4 milhões de novas infecções ocorrem a cada ano.   No Brasil, de acordo com a Sociedade Brasileira de Hepatologia estima-se que são 2,5 milhões de pessoas com Hepatite C e, destas, cerca de 70% não sabe que tem a doença, acarretando um atraso na avaliação médica da doença.

Informações adicionais sobre os estudos de Fase III da AbbVie podem ser encontradas em www.clinicaltrials.gov.

Programa de Pesquisa em Hepatite C da AbbVie

O programa de desenvolvimento clínico de Hepatite C tem a meta de avançar o conhecimento científico e clínico, pela pesquisa de um regime de tratamento totalmente oral, com ou sem ribavirina, que gere altas taxas de resposta virológica ("eliminação do vírus") sustentada no maior número possível de pacientes, incluindo aqueles que geralmente não respondem bem ao tratamento atual, como pacientes que não respondem à terapia baseada em interferon, ou pacientes com fibrose hepática avançada ou cirrose.

Sobre a AbbVie

A AbbVie é uma empresa biofarmacêutica global, com foco em pesquisa, criada em 2013, a partir de sua separação da Abbott. A missão da companhia é usar sua experiência, seus talentos e abordagem única para inovação no desenvolvimento e comercialização de terapias avançadas para algumas das doenças mais graves e complexas do mundo. A AbbVie possui cerca de 25.000 colaboradores em todo o mundo e comercializa seus medicamentos em mais de 170 países. Para mais informações sobre a AbbVie, sua equipe, portfólio e compromissos, acesse www.abbvie.com.  Siga @abbvie no Twitter ou conheça as oportunidades de carreira em nossas páginas no  Facebook ou LinkedIn.

No Brasil, a AbbVie iniciou formalmente suas operações no início de 2014.  Para mais informações, acesse www.abbvie.com.br.

1. Comparação baseada na avaliação dos dados, conforme consta em www. clinicaltrials.gov, referente aos programas da Gilead, BMS e BI, em 15 de novembro de 2013.



Contato:
 Patricia Sant`Anna [email protected]
(Telefone para imprensa: +55 11 3289-2699, ramal 101/107, com Maria José Arrojo)

FONTE AbbVie Brasil

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