{"id":4108,"date":"2025-07-16T10:53:45","date_gmt":"2025-07-16T07:53:45","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4108"},"modified":"2025-07-16T10:53:47","modified_gmt":"2025-07-16T07:53:47","slug":"sarepta-therapeutics-halts-elevidys-shipments-for-non-ambulatory-dmd-patients","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/es\/sarepta-therapeutics-halts-elevidys-shipments-for-non-ambulatory-dmd-patients\/","title":{"rendered":"Sarepta Therapeutics suspende los env\u00edos de ELEVIDYS para pacientes con DMD no ambulatorios"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Debido a dos incidentes documentados de insuficiencia hep\u00e1tica grave que resultaron en muerte, Sarepta Therapeutics ha dejado de enviar su tratamiento gen\u00e9tico ELEVIDYS para personas con distrofia muscular de Duchenne no ambulatoria.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El paciente que falleci\u00f3 m\u00e1s recientemente ten\u00eda 15 a\u00f1os. Para permitir cambios en el protocolo y consideraciones regulatorias, Sarepta ha decidido suspender el ensayo confirmatorio de fase 3 ENVISION (SRP-9001-303), que incluye adultos ambulatorios y no ambulatorios, debido a estos eventos adversos graves. <strong>Leer m\u00e1s<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/es\/three-ongoing-clinical-trials-of-elevidys-gene-therapy-temporarily-halted-in-europe\/\">Tres ensayos cl\u00ednicos en curso de la terapia g\u00e9nica Elevidys se suspenden temporalmente en Europa<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Los dos casos mortales se notificaron en junio de 2025, y el 24 de junio de 2025, el FDA emiti\u00f3 un comunicado de seguridad para investigar el posible riesgo de insuficiencia hep\u00e1tica aguda asociado con ELEVIDYS. En respuesta, Sarepta suspendi\u00f3 su ensayo de fase 3 ENVISION para actualizar los protocolos y consultar con los organismos reguladores. La compa\u00f1\u00eda tambi\u00e9n suspendi\u00f3 temporalmente la distribuci\u00f3n de ELEVIDYS para pacientes no ambulatorios hasta que se apruebe un nuevo r\u00e9gimen inmunosupresor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>M\u00e1s informaci\u00f3n<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/es\/aan-report-reviews-the-state-of-evidence-on-elevidys-gene-therapy-cure-for-duchenne-muscular-dystrophy\/\">Tras la muerte de un segundo paciente, las comunidades de pacientes con distrofia muscular de Duchenne buscan respuestas sobre la terapia g\u00e9nica Elevidys.<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Due to two documented incidents of severe liver failure that resulted in death, Sarepta Therapeutics has stopped shipping its gene treatment ELEVIDYS for individuals with non-ambulatory Duchenne muscular dystrophy. The patient who died most recently was 15 years old. In order to allow for protocol changes and regulatory considerations, Sarepta has decided to halt the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4109,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,65],"class_list":["post-4108","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-sarepta"],"subtitle":"Sarepta ha suspendido temporalmente los env\u00edos de ELEVIDYS para pacientes con distrofia muscular de Duchenne (DMD) no ambulatoria tras la muerte informada de dos pacientes que experimentaron insuficiencia hep\u00e1tica aguda despu\u00e9s del tratamiento con el medicamento.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/4108","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=4108"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/4108\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/4109"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=4108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=4108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=4108"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}