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Home > Press Releases Translations

DNDi, Mundo Sano y Chemo se unen para registrar benznidazol en EE. UU. y Latinoamérica

Río de Janeiro, Brasil — 8 Jun 2016
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Los planes son para ampliar el acceso al tratamiento para la enfermedad de Chagas en las Américas

Con el objetivo de cambiar la actual situación en la que menos del 1 % de las personas que padecen la enfermedad de Chagas tiene acceso al tratamiento, la organización sin ánimo de lucro de desarrollo de medicamentos Drugs for Neglected Diseases initiative (DNDi), el Grupo farmacéutico Chemo y la fundación sin ánimo de lucro Mundo Sano (MS) han iniciado una colaboración formal para ampliar el acceso al benznidazol mediante el registro de este medicamento fundamental para los países afectados por esta enfermedad mortal, incluido EE. UU. En el caso de que Grupo Chemo obtenga de la FDA el vale/voucher -Priority Review Voucher (PRV)-, la compañía se compromete a dedicar la mitad de los ingresos a acciones en beneficio de pacientes con Chagas.
[English] [Português]

Grupo Chemo junto con su partner en Responsabilidad Social Corporativa, Mundo Sano, trabajan para obtener el registro del medicamento para pacientes adultos (100 mg) y pediátricos (12,5 mg) de benznidazol (BZN) con la Administración de Medicamentos y Alimentos de los EE.UU. (FDA), así como para México, Colombia y otros países de Latinoamérica donde la enfermedad es endémica. DNDi apoyará esta medida compartiendo con el Grupo Chemo su conocimiento, experiencia técnica y científica, proporcionando además datos recogidos con sus socios de ensayos clínicos previos.

“Pretendemos acabar con una situación escandalosa e injustificable; prácticamente ninguno de los afectados por la enfermedad de Chagas tiene acceso a los tratamientos disponibles”, afirma el Dr. Bernard Pécoul, Director Ejecutivo de DNDi. “El registro de benznidazol en la FDA nos permitirá superar las dificultades que tienen los pacientes de EE. UU. para obtener el fármaco, y facilitará los procesos de registro en el resto del continente”.

Como parte del acuerdo, Chemo se compromete a garantizar que en los países donde el Chagas es una enfermedad endémica, el BZN esté disponible para el sector público de una forma asequible, es decir, a un precio que cubra los costes de fabricación y distribución con un margen razonable. “Nuestro objetivo es garantizar un acceso extendido e igualitario a todos los pacientes”, declara Leandro Sigman, director general del Grupo Chemo.

“Existen varios obstáculos para el tratamiento del Chagas, pero la primera barrera a superar es tener acceso al fármaco recetado. Nos enorgullece poder contar con Chemo como socio industrial de confianza capaz de producir a gran escala benznidazol de calidad a un coste asequible. Esperamos poder transformar la dinámica de acceso al tratamiento para los pacientes afectados en el conjunto del continente americano”, afirma Silvia Gold, presidente de Mundo Sano.

Para contribuir a solventar esta situación, este acuerdo compromete a DNDi y a MS a desarrollar un ambicioso plan de acceso – en colaboración con partners y stakeholders- destinado a incrementar la demanda de BZN en programas nacionales de salud, consolidando las previsiones de demanda y lanzando campañas de comunicación para aumentar la sensibilización.

Al solicitar el registro de benznidazol a la FDA estadounidense, Chemo podría obtener el vale denominado Priority Review Voucher (PRV), un mecanismo diseñado para promover el I+D en enfermedades desatendidas mediante la emisión de un documento que facilita un procedimiento rápido para la solicitud de registro de otro producto en la FDA. Si Chemo lo obtuviera, el acuerdo alcanzado entre DNDi, MS y Chemo estipula que Mundo Sano recibirá el 50 % de esos ingresos para respaldar sus actividades sin ánimo de lucro. DNDi y MS gestionarían conjuntamente la mitad de esos fondos, que se dedicarían a acciones destinadas al beneficio de los pacientes y a fomentar el acceso al tratamiento, financiando programas sin ánimo de lucro destinados a reforzar el diagnóstico y el tratamiento de la enfermedad de Chagas.

“Desde el primer momento nuestra compañía se ha basado en los valores que comparte con Mundo Sano. Uno de los objetivos del grupo Chemo es proteger y mejorar la salud de las personas, pero también facilitarles el acceso a los tratamientos farmacológicos que necesitan. Trabajar con Mundo Sano nos ha permitido ser conscientes de la alarmante falta de acceso a los medicamentos para el tratamiento de la enfermedad de Chagas. Por este motivo, nos enorgullece colaborar en este proyecto y anunciar nuestro compromiso de dedicar el 50 % de los posibles beneficios del voucher a los pacientes de esta enfermedad olvidada”, aclaró Leandro Sigman.

“Incluso cuando el tratamiento está disponible a un precio asequible, conseguir que los pacientes lo sigan implica la conjunción de muchas acciones complejas, desde superar los desafíos de producción hasta reforzar la capacidad de los sistemas sanitarios o conseguir el apoyo de los pacientes”, aclaró el Dr. Joël Keravec, Director Ejecutivo Regional de DNDi en América Latina. “El desafío reside en capitalizar los valiosos esfuerzos realizados para impulsar el diagnóstico y el tratamiento en países como Colombia, Bolivia, Brasil y EE.UU., así como desarrollar un plan de acceso ambicioso para la enfermedad de Chagas en colaboración con los gobiernos, los proveedores de servicios y las comunidades afectadas”.

El acuerdo recoge el testigo de la colaboración existente entre DNDi y MS destinada a mejorar el acceso al tratamiento del Chagas. En 2013, DNDi aunó sus fuerzas con MS para garantizar una segunda fuente de BZN de calidad contrastada para los pacientes pediátricos. DNDi también ha prestado apoyo a Chemo para el registro de BZN en México y Colombia. Esta nueva colaboración amplía los planes de solicitud de registro a otros países de la región donde la enfermedad es endémica.

CONTACTOS

Chemo: comunicacion@chemogroup.net

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

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

Policy advocacy Partnership Chagas disease

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