{"id":157324,"date":"2026-04-27T01:39:06","date_gmt":"2026-04-27T01:39:06","guid":{"rendered":"http:\/\/69ee947d1dd18a0c2645ddeb"},"modified":"2026-04-27T01:39:06","modified_gmt":"2026-04-27T01:39:06","slug":"ee-uu-aprueba-la-primera-terapia-genica-disenada-para-curar-una-rara-forma-de-sordera","status":"publish","type":"post","link":"https:\/\/sarmiento24h.com\/?p=157324","title":{"rendered":"EE UU aprueba la primera terapia g\u00e9nica dise\u00f1ada para curar una rara forma de sordera"},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en ingl\u00e9s) aprob\u00f3 esta semana una terapia g\u00e9nica dise\u00f1ada para tratar una forma hereditaria de sordera. El tratamiento, llamado Otarmeni y el primero de su tipo, ofrece una alternativa que no solo compensa la p\u00e9rdida auditiva, sino que intenta corregir su causa gen\u00e9tica.<\/p>\n<p>La p\u00e9rdida auditiva cong\u00e9nita afecta a miles de personas en el mundo; entre una y tres personas de cada 1,000 nacen con esta enfermedad. En la mitad de los casos, su origen es una mutaci\u00f3n gen\u00e9tica. Entre otras causas, las mutaciones en el <a href=\"https:\/\/es.wired.com\/articulos\/una-nueva-inyeccion-es-capaz-de-recuperar-la-audicion-con-una-sola-dosis\">gen OTOF<\/a> representan un porcentaje relevante de los casos de sordera no sindr\u00f3mica (del 2 al 8%). Este gen es esencial en la producci\u00f3n de otoferlina, una prote\u00edna clave en las c\u00e9lulas del o\u00eddo interno que permite convertir las vibraciones sonoras en se\u00f1ales el\u00e9ctricas que el cerebro puede interpretar.<\/p>\n<p>Cuando ambas copias del gen OTOF est\u00e1n alteradas, este proceso se interrumpe, lo que provoca una p\u00e9rdida auditiva severa o profunda desde el nacimiento. Algunos dispositivos como aud\u00edfonos o implantes cocleares ayudan a mejorar la percepci\u00f3n del sonido, mas no corrigen el defecto biol\u00f3gico subyacente.<\/p>\n<hr>\n<div class=\"ContentCardEmbedWrapper-hkvhYu kMYDit content-card-embed content-card-embed--stacked\" data-testid=\"ContentCardEmbedWrapper\" readability=\"20.06711409396\">\n<div class=\"ContentCardEmbedImage-bqahne fjmzkP content-card-embed__image\" data-testid=\"ContentCardEmbedImage\"><span class=\"SpanWrapper-kFnjvc eKnjjD responsive-asset\"><picture class=\"ResponsiveImagePicture-jKunQM gjCCFj responsive-image\"><img decoding=\"async\" alt=\"Trump drogas psicod\u00e9licas\" loading=\"lazy\" class=\"ResponsiveImageContainer-dkeESL cQPiWi responsive-image__image\" srcset=\"https:\/\/media.es.wired.com\/photos\/69e501dd1543f6f2f2947250\/master\/w_120,c_limit\/trumpdrogas.jpg 120w, https:\/\/media.es.wired.com\/photos\/69e501dd1543f6f2f2947250\/master\/w_240,c_limit\/trumpdrogas.jpg 240w, https:\/\/media.es.wired.com\/photos\/69e501dd1543f6f2f2947250\/master\/w_320,c_limit\/trumpdrogas.jpg 320w, https:\/\/media.es.wired.com\/photos\/69e501dd1543f6f2f2947250\/master\/w_640,c_limit\/trumpdrogas.jpg 640w\" sizes=\"100vw\" src=\"https:\/\/media.es.wired.com\/photos\/69e501dd1543f6f2f2947250\/master\/w_775%2Cc_limit\/trumpdrogas.jpg\"><\/picture><\/span><\/div>\n<div class=\"ContentCardEmbedInfo-buyHWH gWLOee\" readability=\"21.610738255034\">\n<div class=\"BaseText-fEwdHD ContentCardEmbedHed-kDKGDs fUtEc dlHXUJ content-card-embed__hed\" data-testid=\"ContentCardEmbedHed\"><a class=\"BaseLink-haTOKm ContentCardEmbedHedLink-iBZsco gAoKdC hhUFQU content-card-embed__hed-link link\" href=\"https:\/\/es.wired.com\/articulos\/me-pueden-dar-un-poco-trump-da-luz-verde-a-investigaciones-con-drogas-psicodelicas-para-usos-medicinales\" data-testid=\"ContentCardEmbedHedLink\">\u201c\u00bfMe pueden dar un poco?\u201d: Trump da luz verde a investigaciones de drogas psicod\u00e9licas para usos medicinales<\/a><\/div>\n<p>El presidente Donald Trump firm\u00f3 un decreto para acelerar la investigaci\u00f3n federal de psicod\u00e9licos (iboga\u00edna, psilocibina, MDMA) como terapia para adicciones y trastornos mentales.<\/p>\n<\/div>\n<\/div>\n<hr>\n<h2>C\u00f3mo funciona el tratamiento<\/h2>\n<p>Otarmeni es una terapia g\u00e9nica basada en vectores de virus adenoasociados (AAV), dise\u00f1ados para transportar una copia funcional del gen OTOF directamente a las c\u00e9lulas del o\u00eddo interno.<\/p>\n<p>El procedimiento consiste en una \u00fanica intervenci\u00f3n quir\u00fargica en la que el tratamiento se administra a trav\u00e9s de una infusi\u00f3n en la c\u00f3clea, una estructura del o\u00eddo interno con forma de espiral que se encarga de la audici\u00f3n. Una vez all\u00ed, el gen introducido permite que las c\u00e9lulas vuelvan a producir otoferlina, restaurando la capacidad de transmitir se\u00f1ales sonoras al cerebro.<\/p>\n<p>Este enfoque no requiere tratamientos repetidos; se trata m\u00e1s bien de una terapia de una sola administraci\u00f3n con efectos potencialmente duraderos.<\/p>\n<p>China est\u00e1 trabajando en <a href=\"https:\/\/es.wired.com\/articulos\/la-terapia-genetica-para-la-sordera-hereditaria-avanza-cinco-ninos-logran-escuchar-tras-tratamiento\">un tratamiento similar<\/a>.<\/p>\n<h2>Resultados cl\u00ednicos prometedores<\/h2>\n<p>La aprobaci\u00f3n de la FDA se bas\u00f3 en datos de ensayos cl\u00ednicos en curso que mostraron mejoras considerables en la audici\u00f3n de pacientes pedi\u00e1tricos. En un estudio con ni\u00f1os de entre 10 meses y 16 a\u00f1os, el 80% de participantes experiment\u00f3 una recuperaci\u00f3n notable de la capacidad auditiva luego de recibir el tratamiento.<\/p>\n<p>Resultados adicionales indican que una proporci\u00f3n importante (42%) alcanz\u00f3 niveles de audici\u00f3n suficientes para percibir sonidos cotidianos e incluso susurros, algo impensable antes de esta intervenci\u00f3n.<\/p>\n<p>Estos hallazgos son especialmente relevantes porque la sordera cong\u00e9nita puede afectar el desarrollo del lenguaje y la comunicaci\u00f3n si no se trata desde una etapa temprana. La posibilidad de restaurar la audici\u00f3n desde etapas iniciales podr\u00eda tener un impacto profundo en la calidad de vida de los pacientes.<\/p>\n<p>El tratamiento fue aprobado bajo el programa de vales de prioridad nacional (<em>national priority voucher<\/em>) de la FDA, una iniciativa del gobierno federal que busca acelerar el desarrollo y evaluaci\u00f3n de terapias innovadoras para enfermedades con necesidades m\u00e9dicas no cubiertas. En este caso, la revisi\u00f3n se complet\u00f3 en apenas 61 d\u00edas, uno de los tiempos m\u00e1s r\u00e1pidos registrados para este tipo de productos.<\/p>\n<p>\u201cLa aprobaci\u00f3n de hoy representa un hito importante en el tratamiento de la p\u00e9rdida auditiva gen\u00e9tica\u201d, <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-ever-gene-therapy-treatment-genetic-hearing-loss-under-national-priority-voucher\">dijo Marty Makary<\/a>, comisionado de la FDA. \u201cA trav\u00e9s del programa piloto de vales de prioridad nacional, la agencia est\u00e1 acelerando las terapias para enfermedades raras con necesidades m\u00e9dicas no cubiertas, al tiempo que demuestra que podemos revisar con \u00e9xito incluso las solicitudes m\u00e1s complejas, como las nuevas terapias g\u00e9nicas de doble vector y los productos combinados que requieren la coordinaci\u00f3n entre m\u00faltiples oficinas y centros, en plazos significativamente m\u00e1s cortos\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":157325,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[46],"tags":[],"class_list":["post-157324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tecnologia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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