{"id":2233,"date":"2026-09-20T11:02:15","date_gmt":"2026-09-20T08:02:15","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=2233"},"modified":"2026-09-20T11:11:13","modified_gmt":"2026-09-20T08:11:13","slug":"in-which-countries-is-elevidys-approved-is-elevidys-approved-in-europe","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/fr\/in-which-countries-is-elevidys-approved-is-elevidys-approved-in-europe\/","title":{"rendered":"Dans quels pays le Elevidys est-il homologu\u00e9 ? Le Elevidys est-il homologu\u00e9 en Europe ?"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Elevidys (d\u00e9landistrog\u00e8ne mox\u00e9parvovec) est une th\u00e9rapie g\u00e9nique d\u00e9velopp\u00e9e pour traiter la dystrophie musculaire de Duchenne (DMD). Approuv\u00e9e initialement aux \u00c9tats-Unis, elle a ensuite re\u00e7u l&#039;approbation des autorit\u00e9s r\u00e9glementaires dans plusieurs autres pays. Cependant, Elevidys n&#039;est actuellement pas autoris\u00e9e dans l&#039;Union europ\u00e9enne.<\/strong><\/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=\"#in-which-countries-is-elevidys-approved\">Dans quels pays le Elevidys est-il approuv\u00e9\u00a0?<\/a><\/li><li><a href=\"#is-elevidys-approved-in-europe\">Le mod\u00e8le Elevidys est-il homologu\u00e9 en Europe\u00a0?<\/a><ul><li><a href=\"#what-does-the-ema-negative-opinion-mean\">Que signifie l&#039;avis n\u00e9gatif concernant le EMA\u00a0?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 id=\"in-which-countries-is-elevidys-approved\" class=\"wp-block-heading\">Dans quels pays le Elevidys est-il approuv\u00e9\u00a0?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>En 2026, la norme Elevidys \u00e9tait approuv\u00e9e dans huit pays\u00a0:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00c9tats-Unis<\/li>\n\n\n\n<li>Japon<\/li>\n\n\n\n<li>Isra\u00ebl<\/li>\n\n\n\n<li>\u00c9mirats arabes unis<\/li>\n\n\n\n<li>Oman<\/li>\n\n\n\n<li>Bahre\u00efn<\/li>\n\n\n\n<li>Qatar<\/li>\n\n\n\n<li>Koweit<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1024x576.jpg\" alt=\"Le Elevidys est homologu\u00e9 dans 8 pays, dont les \u00c9tats-Unis, le Japon, Isra\u00ebl, les \u00c9mirats arabes unis, Oman, Bahre\u00efn, le Qatar et le Kowe\u00eft.\" class=\"wp-image-8752\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1024x576.jpg 1024w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-300x169.jpg 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-768x432.jpg 768w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1536x864.jpg 1536w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-18x10.jpg 18w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-746x420.jpg 746w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-150x84.jpg 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-696x392.jpg 696w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1068x601.jpg 1068w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">La tranche d&#039;\u00e2ge approuv\u00e9e, les exigences en mati\u00e8re de mobilit\u00e9 et les autres crit\u00e8res d&#039;admissibilit\u00e9 varient d&#039;un pays \u00e0 l&#039;autre. <strong>Aux \u00c9tats-Unis, le code FDA d\u00e9signe actuellement le code Elevidys pour les patients ambulatoires \u00e2g\u00e9s de 4 ans et plus pr\u00e9sentant une mutation DMD confirm\u00e9e.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le Japon, le Br\u00e9sil, Isra\u00ebl et les pays du Golfe ont leurs propres r\u00e9glementations nationales et indications approuv\u00e9es. Par cons\u00e9quent, l&#039;approbation dans un pays ne signifie pas automatiquement qu&#039;un patient est \u00e9ligible au traitement dans un autre.<\/p>\n\n\n\n<h2 id=\"is-elevidys-approved-in-europe\" class=\"wp-block-heading\">Le mod\u00e8le Elevidys est-il homologu\u00e9 en Europe\u00a0?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Le produit n\u00b0 Elevidys n&#039;est pas homologu\u00e9 dans l&#039;Union europ\u00e9enne.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;Agence europ\u00e9enne des m\u00e9dicaments (EMA) a examin\u00e9 la demande d&#039;autorisation de mise sur le march\u00e9 de Roche pour le Elevidys. <strong>Le 24 juillet 2025, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) du TP175T a \u00e9mis un avis n\u00e9gatif, recommandant le refus de l\u2019autorisation de mise sur le march\u00e9.<\/strong> En savoir plus: <a href=\"https:\/\/dmdwarrior.com\/fr\/why-elevidys-was-not-approved-by-the-european-medicines-agency-ema\/\" target=\"_blank\" rel=\"noreferrer noopener\">Pourquoi le Elevidys n&#039;a-t-il pas \u00e9t\u00e9 approuv\u00e9 par le EMA\u00a0?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L\u2019\u00e9tude pivotale EMA a indiqu\u00e9 qu\u2019elle n\u2019avait pas d\u00e9montr\u00e9 d\u2019am\u00e9lioration statistiquement significative du score NSAA (North Star Ambulatory Assessment) apr\u00e8s 12 mois par rapport au placebo. Elle a \u00e9galement not\u00e9 que l\u2019expression de la dystrophine observ\u00e9e n\u2019\u00e9tait pas corr\u00e9l\u00e9e \u00e0 une am\u00e9lioration de la capacit\u00e9 motrice.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Cela signifie que le Elevidys ne b\u00e9n\u00e9ficie actuellement pas d&#039;une autorisation de mise sur le march\u00e9 \u00e0 l&#039;\u00e9chelle de l&#039;UE.<\/strong><\/p>\n\n\n\n<h3 id=\"what-does-the-ema-negative-opinion-mean\" class=\"wp-block-heading\">Que signifie l&#039;avis n\u00e9gatif concernant le EMA\u00a0?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">La d\u00e9cision relative \u00e0 l&#039;autorisation EMA s&#039;applique au processus r\u00e9glementaire de l&#039;Union europ\u00e9enne. Elle n&#039;annule pas les autorisations Elevidys accord\u00e9es par les autorit\u00e9s r\u00e9glementaires d&#039;autres pays.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche a d\u00e9clar\u00e9 qu&#039;elle entendait poursuivre les discussions avec les autorit\u00e9s r\u00e9glementaires europ\u00e9ennes et explorer une voie potentielle pour rendre le Elevidys disponible aux personnes atteintes de DMD dans l&#039;UE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les familles doivent donc faire la distinction entre\u00a0:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Homologation FDA aux \u00c9tats-Unis \u2192 Oui<\/strong><br><strong>Approbation dans plusieurs autres pays \u2192 Oui<\/strong><br><strong>Approbation Union europ\u00e9enne\/EMA \u2192 Non, suite \u00e0 l&#039;avis n\u00e9gatif<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pour plus d&#039;informations\u00a0: <a href=\"https:\/\/dmdwarrior.com\/fr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Foire aux questions sur le Elevidys<\/strong><\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Important:<\/strong> Les autorisations r\u00e9glementaires et les crit\u00e8res d&#039;admissibilit\u00e9 aux traitements peuvent \u00e9voluer. Les patients et leurs familles doivent se renseigner aupr\u00e8s des autorit\u00e9s comp\u00e9tentes de leur pays et d&#039;un sp\u00e9cialiste qualifi\u00e9 en DMD afin de v\u00e9rifier la situation actuelle et les conditions d&#039;admissibilit\u00e9 locales.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">D\u00e9couvrez maintenant : <a href=\"https:\/\/dmdwarrior.com\/fr\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Centre d&#039;essais cliniques sur la DMD de DMDWarrior<\/strong><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Elevidys (delandistrogene moxeparvovec) is a gene therapy developed for Duchenne muscular dystrophy (DMD). It was first approved in the United States and has subsequently received regulatory approvals in several other countries. However, Elevidys is not currently approved in the European Union. In Which Countries Is Elevidys Approved? As of 2026, Elevidys is approved in eight [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":8753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[95,33,91,84,61,910,142,94,96,93,65,92,79],"class_list":["post-2233","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-bahrain","tag-elevidys","tag-ema","tag-europe","tag-gene-therapy","tag-israel","tag-japan","tag-kuwait","tag-oman","tag-qatar","tag-sarepta","tag-united-arab-emirates","tag-usa"],"subtitle":"O\u00f9 le g\u00e8ne Elevidys est-il approuv\u00e9 et dans quels pays cette th\u00e9rapie g\u00e9nique contre la dystrophie musculaire de Duchenne (DMD) est-elle disponible ? D\u00e9couvrez les derniers pays ayant approuv\u00e9 le g\u00e8ne Elevidys et v\u00e9rifiez s\u2019il est approuv\u00e9 en Europe.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/2233","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\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/comments?post=2233"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/2233\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/8753"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=2233"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=2233"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=2233"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}