{"id":48655,"date":"2026-08-24T16:45:56","date_gmt":"2026-08-24T16:45:56","guid":{"rendered":"https:\/\/jornalboasnoticias.com.br\/home\/?p=48655"},"modified":"2026-08-24T16:45:56","modified_gmt":"2026-08-24T16:45:56","slug":"anvisa-e-roche-cancelam-registro-de-elevidys-para-doenca-rara","status":"publish","type":"post","link":"https:\/\/jornalboasnoticias.com.br\/home\/anvisa-e-roche-cancelam-registro-de-elevidys-para-doenca-rara\/","title":{"rendered":"Anvisa e Roche cancelam registro de Elevidys para doen\u00e7a rara"},"content":{"rendered":"<blockquote>\n<p style=\"text-align: center;\">Terapia para Distrofia Muscular de Duchenne requer mais dados<\/p>\n<\/blockquote>\n<figure id=\"attachment_48656\" aria-describedby=\"caption-attachment-48656\" style=\"width: 1170px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-48656\" src=\"https:\/\/jornalboasnoticias.com.br\/home\/wp-content\/uploads\/2026\/08\/captura_de_tela_2026-08-24_133043_copy.webp\" alt=\"\" width=\"1170\" height=\"700\" srcset=\"https:\/\/jornalboasnoticias.com.br\/home\/wp-content\/uploads\/2026\/08\/captura_de_tela_2026-08-24_133043_copy.webp 1170w, https:\/\/jornalboasnoticias.com.br\/home\/wp-content\/uploads\/2026\/08\/captura_de_tela_2026-08-24_133043_copy-300x179.webp 300w, https:\/\/jornalboasnoticias.com.br\/home\/wp-content\/uploads\/2026\/08\/captura_de_tela_2026-08-24_133043_copy-1024x613.webp 1024w, https:\/\/jornalboasnoticias.com.br\/home\/wp-content\/uploads\/2026\/08\/captura_de_tela_2026-08-24_133043_copy-768x459.webp 768w\" sizes=\"auto, (max-width: 1170px) 100vw, 1170px\" \/><figcaption id=\"caption-attachment-48656\" class=\"wp-caption-text\">\u00a9 Matheus Brasil\/Minist\u00e9rio da Sa\u00fade<\/figcaption><\/figure>\n<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) e a empresa Roche comunicaram nesta segunda-feira (24)\u00a0o cancelamento do registro condicional do medicamento Elevidys\u00ae (delandistrogeno moxeparvoveque), a pedido da farmac\u00eautica. O registro condicional \u00e9 uma autoriza\u00e7\u00e3o tempor\u00e1ria de uso ou comercializa\u00e7\u00e3o de um produto no pa\u00eds.\u00a0<a href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/resolucao-re-n-3.332-de-21-de-agosto-de-20226-727301008\" target=\"_blank\" rel=\"noopener\">A medida foi\u00a0publicada no Di\u00e1rio Oficial da Uni\u00e3o<\/a>.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1700476&amp;o=node\" \/><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1700476&amp;o=node\" \/><\/p>\n<p>A interrup\u00e7\u00e3o foi adotada ap\u00f3s o entendimento de que os dados dispon\u00edveis at\u00e9 este momento sobre o Elevidys disponibilizados pela empresa fabricante n\u00e3o atendem aos requisitos de regula\u00e7\u00e3o necess\u00e1rios para manuten\u00e7\u00e3o do registro condicional no pa\u00eds.<\/p>\n<p>A Anvisa esclarece que o cancelamento do registro n\u00e3o altera as obriga\u00e7\u00f5es da empresa relacionadas ao acompanhamento dos pacientes previamente expostos ao medicamento nos estudos cl\u00ednicos e tamb\u00e9m nos programas existentes, incluindo os pacientes infantis brasileiros que receberam Elevidys\u00ae entre dezembro de 2024 e julho de 2025.<\/p>\n<p>O medicamento Elevidys \u00e9 indicado para pacientes com Distrofia Muscular de Duchenne (DMD). A doen\u00e7a gen\u00e9tica rara compromete progressivamente a musculatura \u2013 o que causa perda de massa muscular e fraqueza \u2013 devido ao impedimento da produ\u00e7\u00e3o adequada de distrofina, prote\u00edna considerada essencial para o funcionamento dos m\u00fasculos.<\/p>\n<h2>Cronologia<\/h2>\n<p>O medicamento Elevidys\u00ae obteve registro condicional no Brasil em dezembro de 2024, em car\u00e1ter excepcional, com exig\u00eancia de apresenta\u00e7\u00e3o posterior de dados complementares sobre efic\u00e1cia e seguran\u00e7a no uso.<\/p>\n<p>No pa\u00eds, o Elevidys foi autorizado para tratamento da Distrofia Muscular de Duchenne (DMD) e em pacientes deambuladores, ou seja, em crian\u00e7as que ainda mant\u00eam a capacidade de andar de forma independente ou com aux\u00edlio, com idade entre 4 e 7 anos, e que atendiam a crit\u00e9rios cl\u00ednicos e laboratoriais espec\u00edficos \u00e0 \u00e9poca.<\/p>\n<p>Em julho de 2025, a comercializa\u00e7\u00e3o do produto no Brasil foi suspensa pela ag\u00eancia reguladora por meio da Resolu\u00e7\u00e3o (RE) 2.813\/2025, no aguardo de novos estudos e respostas da farmac\u00eautica para avaliar se os benef\u00edcios da medica\u00e7\u00e3o. A medida foi tomada em raz\u00e3o de relatos de casos fatais de insufici\u00eancia hep\u00e1tica aguda em pacientes tratados com o produto nos Estados Unidos.<\/p>\n<p>Em junho deste ano, em uma audi\u00eancia p\u00fablica na Comiss\u00e3o de Defesa dos Direitos das Pessoas com Defici\u00eancia da C\u00e2mara dos Deputados foram relatados estes alertas graves de seguran\u00e7a do produto.<\/p>\n<p>Desde a suspens\u00e3o, a Anvisa diz ter\u00a0encaminhado uma s\u00e9rie de exig\u00eancias formais \u00e0 empresa respons\u00e1vel pelo medicamento. Entre elas, est\u00e3o a apresenta\u00e7\u00e3o de dados consolidados de seguran\u00e7a, com foco em insufici\u00eancia hep\u00e1tica aguda.<\/p>\n<p>Segundo a Anvisa, nesse per\u00edodo, a Roche apresentou informa\u00e7\u00f5es complementares e manteve intera\u00e7\u00e3o cont\u00ednua com a Anvisa no contexto das obriga\u00e7\u00f5es regulat\u00f3rias associadas ao registro condicional.<\/p>\n<p>Em nota, a Roche diz que segue empenhada com o programa cl\u00ednico do Elevidys\u00ae e com a apresenta\u00e7\u00e3o das evid\u00eancias necess\u00e1rias.<\/p>\n<p>As duas partes tamb\u00e9m reafirmaram o compromisso com a sa\u00fade da popula\u00e7\u00e3o e decis\u00f5es regulat\u00f3rias fundamentadas nas melhores evid\u00eancias cient\u00edficas dispon\u00edveis, especialmente, de terapias avan\u00e7adas para o tratar doen\u00e7as graves e raras.<\/p>\n<p>Paralelamente, na \u00faltima quinta-feira (13), a Anvisa aprovou o registro de outro medicamento indicado para pacientes com DMD, o Duvyzat (givinostate). Os estudos cl\u00ednicos demonstraram que o novo produto \u00e9 capaz de retardar a progress\u00e3o da doen\u00e7a.<\/p>\n<p><em>Ag\u00eancia Brasil<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Terapia para Distrofia Muscular de Duchenne requer mais dados A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria<\/p>\n","protected":false},"author":3,"featured_media":48656,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-48655","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa e Roche cancelam registro de Elevidys para doen\u00e7a rara - Jornal<\/title>\n<meta name=\"description\" content=\"Anvisa e Roche cancelam registro de Elevidys para doen\u00e7a rara\" 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