{"id":4219,"date":"2025-07-25T14:33:50","date_gmt":"2025-07-25T11:33:50","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4219"},"modified":"2025-07-25T15:19:18","modified_gmt":"2025-07-25T12:19:18","slug":"brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/pt\/brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec\/","title":{"rendered":"Brasil suspende uso de ELEVIDYS (delandistrogene moxeparvovec)"},"content":{"rendered":"<p class=\"wp-block-paragraph\">A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) anunciou que suspendeu temporariamente a comercializa\u00e7\u00e3o, distribui\u00e7\u00e3o, fabrica\u00e7\u00e3o, importa\u00e7\u00e3o, publicidade e uso do medicamento de terapia g\u00eanica Elevidys (delandistrog\u00eanio moxeparvovek) no Brasil como medida de precau\u00e7\u00e3o. A suspens\u00e3o permanecer\u00e1 em vigor at\u00e9 que as recentes incertezas de seguran\u00e7a relacionadas a casos fatais de insufici\u00eancia hep\u00e1tica aguda em pacientes tratados com o produto nos Estados Unidos sejam totalmente esclarecidas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esta decis\u00e3o foi tomada \u00e0 luz de novas informa\u00e7\u00f5es regulat\u00f3rias publicadas pela Food and Drug Administration dos EUA (FDA), relatando tr\u00eas mortes associadas ao uso de produtos de terapia gen\u00e9tica com tecnologia de vetor AAVrh74 desenvolvida pela Sarepta Therapeutics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dois casos envolveram pacientes pedi\u00e1tricos n\u00e3o deambuladores com Distrofia Muscular de Duchenne (DMD) tratados com Elevidys, e o terceiro caso envolveu um paciente adulto com Distrofia Muscular de Cinturas-Membros que estava recebendo um produto de terapia gen\u00e9tica experimental baseado no mesmo vetor viral. Ambos os eventos envolveram progress\u00e3o para insufici\u00eancia hep\u00e1tica aguda com desfecho fatal.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Saber mais: <a href=\"https:\/\/dmdwarrior.com\/pt\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/\" target=\"_blank\" rel=\"noreferrer noopener\">Roche suspende remessas de terapia gen\u00e9tica Elevidys para fora dos Estados Unidos<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Saber mais: <a href=\"https:\/\/dmdwarrior.com\/pt\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/\" target=\"_blank\" data-type=\"post\" data-id=\"4222\" rel=\"noreferrer noopener\">A Ag\u00eancia Europeia de Medicamentos (EMA) emitiu um parecer negativo sobre o Elevidys<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The Brazilian Health Regulatory Agency (Anvisa) announced that it has temporarily suspended the marketing, distribution, manufacturing, import, advertising, and use of the gene therapy drug Elevidys (delandistrogen moxeparvovek) in Brazil as a precautionary measure. The suspension will remain in effect until recent safety uncertainties related to fatal cases of acute liver failure in patients treated [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4220,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[180,82,121,33,179],"class_list":["post-4219","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-anvisa","tag-brazil","tag-delandistrogene-moxeparvovec","tag-elevidys","tag-elevidys-gene-therapy"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/4219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/comments?post=4219"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/4219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/4220"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=4219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=4219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=4219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}