{"id":4362,"date":"2025-08-25T16:43:15","date_gmt":"2025-08-25T13:43:15","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4362"},"modified":"2025-08-25T16:46:42","modified_gmt":"2025-08-25T13:46:42","slug":"duvyzat-givinostat-positive-long-term-data-from-phase-2-and-phase-3-epidys-trials","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/fr\/duvyzat-givinostat-positive-long-term-data-from-phase-2-and-phase-3-epidys-trials\/","title":{"rendered":"ITF Therapeutics annonce la publication de donn\u00e9es positives \u00e0 long terme renfor\u00e7ant l&#039;efficacit\u00e9 et l&#039;innocuit\u00e9 du Duvyzat (Givinostat) comme traitement de la dystrophie musculaire de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">ITF Therapeutics, filiale d&#039;Italfarmaco, a annonc\u00e9 aujourd&#039;hui la publication de donn\u00e9es positives sur l&#039;innocuit\u00e9 et l&#039;efficacit\u00e9 \u00e0 long terme du Duvyzat (Givinostat) en tant que traitement de la dystrophie musculaire de Duchenne (DMD) issues des extensions ouvertes des essais de phase 2 et de phase 3 (EPIDYS) de la soci\u00e9t\u00e9.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les r\u00e9sultats, publi\u00e9s dans Annals of Clinical and Translational Neurology, montrent qu&#039;un traitement \u00e0 long terme avec le givinostat, un nouvel inhibiteur de l&#039;histone d\u00e9sac\u00e9tylase (HDAC), en association avec des corticost\u00e9ro\u00efdes, a retard\u00e9 la progression de la maladie chez les patients ambulatoires \u00e2g\u00e9s de six ans et plus atteints de DMD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Apprendre encore plus<\/strong>:&nbsp;<a href=\"https:\/\/dmdwarrior.com\/fr\/duvyzat-givinostat-nonsteroidal-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">Qu&#039;est-ce que Duvyzat (Givinostat) ?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Il est important de noter qu&#039;un b\u00e9n\u00e9fice clinique a \u00e9t\u00e9 observ\u00e9 dans tous les groupes de traitement recevant du givinostat, avec un impact positif sur les fonctions motrices cl\u00e9s telles que se lever du sol, monter les escaliers et marcher (ambulation). Le givinostat a re\u00e7u une autorisation de mise sur le march\u00e9 aux \u00c9tats-Unis, dans l&#039;UE et au Royaume-Uni.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>De nouvelles donn\u00e9es publi\u00e9es dans Annals of Clinical and Translational Neurology montrent qu&#039;un traitement \u00e0 long terme avec le givinostat peut retarder consid\u00e9rablement la perte de fonctions cl\u00e9s de mobilit\u00e9 chez les patients atteints de dystrophie musculaire de Duchenne.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Un b\u00e9n\u00e9fice clinique significatif a \u00e9t\u00e9 observ\u00e9 dans tous les groupes de traitement, quel que soit le stade de la maladie au d\u00e9but.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Le givinostat est rest\u00e9 bien tol\u00e9r\u00e9 lors d\u2019une utilisation prolong\u00e9e, conform\u00e9ment aux essais cliniques pr\u00e9c\u00e9dents.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Le suivi moyen dans l\u2019\u00e9tude d\u2019extension a d\u00e9pass\u00e9 36 mois de traitement, certains patients ayant re\u00e7u un traitement pendant plus de huit ans depuis le d\u00e9but du traitement par givinostat.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;\u00e9tude a port\u00e9 sur plusieurs cohortes de gar\u00e7ons atteints de DMD, tous trait\u00e9s par givinostat pendant des dur\u00e9es variables. Certains avaient d\u00e9j\u00e0 particip\u00e9 aux \u00e9tudes EPIDYS de phase\u00a02 ou de phase\u00a03 \u2013 sous traitement actif ou placebo \u2013 avant de participer \u00e0 l&#039;\u00e9tude de prolongation. D&#039;autres se sont inscrits directement \u00e0 l&#039;\u00e9tude de prolongation apr\u00e8s avoir rempli les crit\u00e8res d&#039;\u00e9ligibilit\u00e9, sans participer \u00e0 l&#039;essai principal. L&#039;exposition totale au traitement pour certains patients a d\u00e9pass\u00e9 huit ans.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Apprendre encore plus<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/fr\/itf-therapeutics-launching-a-study-to-evaluate-the-real-world-experience-of-duvyzat-givinostat-in-patients-with-duchenne-muscular-dystrophy\/\">ITF Therapeutics lance une \u00e9tude visant \u00e0 \u00e9valuer l&#039;exp\u00e9rience r\u00e9elle du Duvyzat (Givinostat) chez les patients atteints de dystrophie musculaire de Duchenne<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>ITF Therapeutics affiliate of Italfarmaco, today announced publication of positive long-term safety and efficacy data for Duvyzat (Givinostat) as a treatment for Duchenne muscular dystrophy (DMD) from the company&#8217;s open-label extensions of its Phase 2 and Phase 3 (EPIDYS) trials. The results, published in Annals of Clinical and Translational Neurology, show that long-term treatment with [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4366,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[46,47,300],"class_list":["post-4362","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-duvyzat","tag-givinostat","tag-itf-therapeutics"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4362","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=4362"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4362\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/4366"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=4362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=4362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=4362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}