{"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\/fr\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics annonce la fin de la r\u00e9union d&#039;\u00e9valuation \u00e0 mi-cycle avec FDA sur Deramiocel pour le traitement de la cardiomyopathie de la dystrophie musculaire de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics, une soci\u00e9t\u00e9 de biotechnologie d\u00e9veloppant des th\u00e9rapies transformatrices \u00e0 base de cellules et d&#039;exosomes pour le traitement des maladies rares, a annonc\u00e9 aujourd&#039;hui l&#039;ach\u00e8vement d&#039;une r\u00e9union d&#039;examen \u00e0 mi-cycle avec la Food and Drug Administration des \u00c9tats-Unis (FDA) pour la demande de licence de produit biologique (BLA) de la soci\u00e9t\u00e9 visant \u00e0 obtenir l&#039;approbation compl\u00e8te du deramiocel, une th\u00e9rapie cellulaire exp\u00e9rimentale, comme traitement pour les patients diagnostiqu\u00e9s avec une cardiomyopathie de dystrophie musculaire de Duchenne (DMD).<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>Table des mati\u00e8res<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">Le Deramiocel FDA est-il approuv\u00e9 ?<\/a><\/li><li><a href=\"#what-is-deramiocel\">Qu&#039;est-ce que Deramiocel ?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">Le Deramiocel FDA est-il approuv\u00e9 ?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Au cours de la r\u00e9union, le FDA a d\u00e9clar\u00e9 qu&#039;aucune lacune importante n&#039;avait \u00e9t\u00e9 identifi\u00e9e par le comit\u00e9 d&#039;examen et que le dossier \u00e9tait en bonne voie pour une date d&#039;action en vertu de la Loi sur les frais d&#039;utilisation des m\u00e9dicaments sur ordonnance (PDUFA) du 31 ao\u00fbt 2025. Le FDA a \u00e9galement confirm\u00e9 son intention de tenir une r\u00e9union du comit\u00e9 consultatif, bien qu&#039;une date officielle n&#039;ait pas encore \u00e9t\u00e9 fix\u00e9e.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">Qu&#039;est-ce que Deramiocel ?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) est constitu\u00e9 de cellules allog\u00e9niques d\u00e9riv\u00e9es de cardiosph\u00e8res (CDC), une population rare de cellules cardiaques dont les \u00e9tudes pr\u00e9cliniques et cliniques ont d\u00e9montr\u00e9 qu&#039;elles exer\u00e7aient de puissantes actions immunomodulatrices et antifibrotiques dans la pr\u00e9servation de la fonction cardiaque et musculaire squelettique dans les dystrophiopathies telles que la DMD. \u2013 En savoir plus : <a href=\"https:\/\/dmdwarrior.com\/fr\/what-is-deramiocel\/\">Qu&#039;est-ce que Deramiocel ? Que fait 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"],"subtitle":"La Food and Drug Administration am\u00e9ricaine (FDA) a termin\u00e9 une r\u00e9union d'examen \u00e0 mi-cycle avec Capricor Therapeutics, pour obtenir l'approbation compl\u00e8te du deramiocel, une th\u00e9rapie cellulaire exp\u00e9rimentale, pour les patients atteints de cardiomyopathie atteinte de dystrophie musculaire de Duchenne (DMD).","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/3798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/comments?post=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}