{"id":4232,"date":"2025-07-26T16:10:18","date_gmt":"2025-07-26T13:10:18","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4232"},"modified":"2025-07-26T16:10:19","modified_gmt":"2025-07-26T13:10:19","slug":"fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/es\/fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys\/","title":{"rendered":"FDA Investigan la muerte de un ni\u00f1o brasile\u00f1o de 8 a\u00f1os que recibi\u00f3 Elevidys"},"content":{"rendered":"<p class=\"wp-block-paragraph\">La Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) investiga la muerte de un ni\u00f1o de 8 a\u00f1os que recibi\u00f3 Elevidys, una terapia g\u00e9nica Sarepta Therapeutics para la distrofia muscular de Duchenne. El fallecimiento ocurri\u00f3 el 7 de junio de 2025. FDA ha solicitado la suspensi\u00f3n voluntaria de la distribuci\u00f3n del producto mientras investiga los problemas de seguridad.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) emiti\u00f3 un comunicado de prensa anunciando una investigaci\u00f3n sobre la muerte de un paciente de ocho a\u00f1os con distrofia muscular de Duchenne (Duchenne) que hab\u00eda recibido terapia g\u00e9nica ELEVIDYS (delandistr\u00f3geno moxeparvovec). <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-investigating-death-8-year-old-boy-who-received-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">Leer m\u00e1s<\/a> \u2013 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Roche a\u00fan no ha proporcionado informaci\u00f3n detallada<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta sinti\u00f3 la necesidad de hacer una declaraci\u00f3n sobre el tema el 25 de julio de 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se consider\u00f3 que la muerte de este paciente no estaba relacionada con el tratamiento con ELEVIDYS. Seg\u00fan inform\u00f3 ayer Naomi Kresge en Bloomberg News:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche Holding AG afirma que la reciente muerte de un paciente en Brasil que hab\u00eda sido tratado con la terapia g\u00e9nica Elevidys para la distrofia muscular de Duchenne no est\u00e1 relacionada con el tratamiento. <a href=\"https:\/\/investorrelations.sarepta.com\/news-releases\/news-release-details\/sarepta-therapeutics-provides-clarifying-statement-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">Declaraci\u00f3n sobre ELEVIDYS<\/a> \u2013 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>El ni\u00f1o no particip\u00f3 en un ensayo cl\u00ednico; el m\u00e9dico que inform\u00f3 el caso evalu\u00f3 que su muerte no estaba relacionada con la terapia gen\u00e9tica, dice Roche en un comunicado.<\/li>\n\n\n\n<li>Se inform\u00f3 de la muerte a las autoridades sanitarias.<\/li>\n\n\n\n<li><strong>Roche, que comercializa el tratamiento para la enfermedad de Duchenne Elevidys de Sarepta fuera de Estados Unidos, se niega a hacer comentarios sobre la edad del ni\u00f1o o los detalles del caso.<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta inform\u00f3 este evento a FDA el 18 de junio de 2025, a trav\u00e9s de la base de datos electr\u00f3nica posterior a la comercializaci\u00f3n de FDA, FAERS.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Leer m\u00e1s: <a href=\"https:\/\/dmdwarrior.com\/es\/dmd-warriors-turkish-representative-shares-his-views-on-elevidys-gene-therapy-is-it-effective-and-why-is-it-expensive\/\" target=\"_blank\" rel=\"noreferrer noopener\">El representante turco de DMD WarrioR comparte sus puntos de vista sobre la terapia gen\u00e9tica Elevidys: \u00bfEs efectiva y por qu\u00e9 es costosa?<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and voluntary suspension of product distribution as it investigates the safety concerns. The U.S. Food and Drug Administration [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4235,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,179,88,203,65],"class_list":["post-4232","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-elevidys-gene-therapy","tag-fda","tag-roche","tag-sarepta"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/4232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/comments?post=4232"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/4232\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/4235"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=4232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=4232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=4232"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}