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Home > Press Releases Translations

DNDi, Mundo Sano e Chemo se unem para registrar benznidazol nos Estados Unidos e América Latina

Rio de Janeiro, Brasil — 8 Jun 2016
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Os planos vão expandir o acesso ao tratamento para doença de Chagas nas Américas

Numa tentativa de reverter uma situação em que menos de 1% das pessoas com doença de Chagas têm acesso ao tratamento, a organização sem fins lucrativos para desenvolvimento de medicamentos DNDi (iniciativa Medicamentos para Doenças Negligenciadas), o laboratório farmacêutico Chemo Group e a fundação filantrópica Mundo Sano estabelecem um acordo formal de colaboração para incrementar o uso do benznidazol. O objetivo é tornar o benznidazol, medicamento essencial no tratamento de Chagas, financeiramente acessível, registrado em países afetados por essa doença fatal, incluindo os Estados Unidos. Se o laboratório Chemo conseguir uma revisão prioritária pelo FDA americano, se compromete a empregar metade da receita a ações que beneficiem pacientes portadores de doença de Chagas.
[English] [Español]

Chemo Group e seu parceiro de responsabilidade social corporativa Mundo Sano estão trabalhando para registrar a formulação de benznidazol (BZN) para adultos (100mg) e crianças (12,5mg) junto ao Food and Drug Administration (FDA) dos Estados Unidos, e também no México, Colômbia e outros países da América Latina onde a doença de Chagas é endêmica. A DNDi apoia essa iniciativa ao compartilhar com o Chemo Group sua experiência técnica e científica, e também fornece dados de formulações para adultos e crianças coletados por parceiros em ensaios clínicos anteriores.

“Nossa ambição é colocar um fim a essa situação escandalosa e injustificável em que quase nenhuma das pessoas portadoras de doença de Chagas têm acesso aos tratamentos disponíveis”, disse o Dr. Bernard Pécoul, Diretor Executivo da DNDi. “O registro do benznidazol no FDA nos permite superar as dificuldades que os pacientes norte-americanos têm de acesso à medicação, e facilitará o processo de registro nos outros países das Américas.”

Como parte do acordo, o Chemo Group compromete-se a disponibilizar o BZN aos governos de países onde a doença de Chagas é endêmica de forma financeiramente viável: com um preço que cubra os custos de produção e distribuição e permita uma margem razoável. “Nosso objetivo é garantir o uso disseminado e o acesso equitativo a todos os pacientes”, disse Leandro Sigman, Diretor Geral do Chemo Group.

“Há muitas barreiras para o tratamento da doença de Chagas, mas a primeira a ser superada é a falta de acesso à medicação prescrita”, disse Silvia Gold, Presidente da Fundação Mundo Sano. “Temos orgulho de contar com o Chemo Group como um parceiro industrial confiável, capaz de produzir benznidazol de qualidade, em quantidade e a um custo financeiramente viável. Nossa esperança é dinamizar o acesso ao tratamento para pacientes portadores de doença de Chagas em todas as Américas”.

Para ajudar a enfrentar essa situação, o acordo estabelece o compromisso de DNDi e Mundo Sano em desenvolver um plano de acesso ambicioso, em colaboração com os atores interessados e parceiros, visando aumentar a demanda por programas nacionais de BZN, melhorando as estimativas de demanda e campanhas de comunicação para conscientização e estímulo à adoção do medicamento.

Ao registrar o BZN no FDA dos Estados Unidos, o Chemo Group pode se qualificar para um vale de revisão prioritária (priority review voucher – PRV), um mecanismo elaborado para estimular P&D em doenças negligenciadas ao conceder um vale que acelera o registro de outro produto no FDA. Se o Chemo Group obtiver esse vale (PRV), o acordo entre DNDi, Mundo Sano e Chemo estipula que a Mundo Sano receberá 50% de qualquer financiamento relacionado ao PRV para apoiar suas atividades filantrópicas. A DNDi e Mundo Sano controlariam, em conjunto, metade dessa verba, que seria empregada em ações que beneficiassem os pacientes e estimulassem o acesso, como o apoio a programas sem fins lucrativos que aumentassem o diagnóstico e o tratamento da doença de Chagas.

“Nossa empresa é baseada em valores que compartilhamos com a Mundo Sano. O Chemo é um grupo voltado à manutenção e melhora da saúde das pessoas, e que também facilita o acesso a tratamentos farmacológicos. Em virtude da alarmante falta de acesso a medicamentos para combater a doença de Chagas, estamos orgulhosos em anunciar nosso compromisso de dedicar 50% de qualquer vantagem econômica que venhamos a obter com o PRV para ajudar as pessoas que vivem com essa doença negligenciada”, disse Leandro Sigman.

“Mesmo existindo um tratamento economicamente viável, fazer com que os pacientes recebam o tratamento envolve a combinação de várias ações complexas, desde superar problemas de produção até incrementar a oferta no sistema de saúde e buscar o apoio dos pacientes”, disse o Dr. Joël Keravec, Diretor Executivo Regional da DNDi América Latina. “O desafio é potencializar os esforços que estão sendo feitos para incrementar o diagnóstico e tratamento em países como a Colômbia, Bolívia, Brasil e Estados Unidos, e desenvolver um plano de amplo alcance para a doença de Chagas em conjunto com governos, profissionais de saúde e comunidades”.

O acordo leva em conta a colaboração já existente entre DNDi e Mundo Sano para expandir o acesso ao tratamento da doença de Chagas. Em 2013, a DNDi se uniu à Mundo Sano para garantir uma fonte segura de BZN para crianças. A DNDi também tem apoiado o Chemo Group em relação ao registro do BZN no México e na Colômbia. Esta nova colaboração amplia os planos de registro para outros países endêmicos da região.

CONTATOS

Chemo: comunicacion@chemogroup.net

DNDi (América Latina): Betina Moura / +55-21-98122-2798 / bmoura@dndi.org

DNDi (Estados Unidos): Ilan Moss / +1-646-266-5216 / imoss@dndi.org

Policy advocacy Partnership Chagas disease

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