{"id":3798,"date":"2025-05-05T15:47:58","date_gmt":"2025-05-05T12:47:58","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3798"},"modified":"2025-05-05T15:49:36","modified_gmt":"2025-05-05T12:49:36","slug":"capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/es\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics anuncia la finalizaci\u00f3n de la reuni\u00f3n de revisi\u00f3n de mitad de ciclo con FDA sobre Deramiocel para el tratamiento de la miocardiopat\u00eda por distrofia muscular de Duchenne."},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics, una empresa de biotecnolog\u00eda que desarrolla terapias transformadoras basadas en c\u00e9lulas y exosomas para el tratamiento de enfermedades raras, anunci\u00f3 hoy la finalizaci\u00f3n de una reuni\u00f3n de revisi\u00f3n de mitad de ciclo con la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) para la Solicitud de Licencia Biol\u00f3gica (BLA) de la Compa\u00f1\u00eda que busca la aprobaci\u00f3n total para deramiocel, una terapia celular en investigaci\u00f3n, como tratamiento para pacientes diagnosticados con miocardiopat\u00eda por distrofia muscular de Duchenne (DMD).<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>Tabla de contenido<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">\u00bfEst\u00e1 aprobado el Deramiocel FDA?<\/a><\/li><li><a href=\"#what-is-deramiocel\">\u00bfQu\u00e9 es Deramiocel?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">\u00bfEst\u00e1 aprobado el Deramiocel FDA?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Durante la reuni\u00f3n, FDA afirm\u00f3 que el Comit\u00e9 de Revisi\u00f3n no ha identificado deficiencias significativas y que el paquete est\u00e1 encaminado hacia una fecha de acci\u00f3n de la Ley de Tarifas para Usuarios de Medicamentos Recetados (PDUFA) del 31 de agosto de 2025. FDA tambi\u00e9n confirm\u00f3 su intenci\u00f3n de celebrar una reuni\u00f3n del comit\u00e9 asesor, aunque a\u00fan no se ha establecido una fecha oficial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">\u00bfQu\u00e9 es Deramiocel?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) consiste en c\u00e9lulas derivadas de cardiosferas (CDC) alog\u00e9nicas, una poblaci\u00f3n poco com\u00fan de c\u00e9lulas card\u00edacas que, seg\u00fan estudios precl\u00ednicos y cl\u00ednicos, ejercen potentes acciones inmunomoduladoras y antifibr\u00f3ticas para preservar la funci\u00f3n del m\u00fasculo card\u00edaco y esquel\u00e9tico en distrofias como la DMD. \u2013 Leer m\u00e1s: <a href=\"https:\/\/dmdwarrior.com\/es\/what-is-deramiocel\/\">\u00bfQu\u00e9 es Deramiocel? \u00bfQu\u00e9 hace CAP-1002?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Capricor Therapeutics , a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company\u2019s Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3800,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,362,88],"class_list":["post-3798","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd-cardiomyopathy","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/3798","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=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}