{"id":4175,"date":"2025-07-23T17:17:54","date_gmt":"2025-07-23T14:17:54","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4175"},"modified":"2025-07-23T17:21:37","modified_gmt":"2025-07-23T14:21:37","slug":"roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/fr\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/","title":{"rendered":"Roche suspend les livraisons de th\u00e9rapie g\u00e9nique Elevidys hors des \u00c9tats-Unis"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Selon la soci\u00e9t\u00e9 pharmaceutique suisse, l&#039;arr\u00eat, qui entrera en vigueur le 22 juillet 2025, concerne les nouvelles commandes de Elevidys dans les pays non am\u00e9ricains qui d\u00e9pendent de l&#039;approbation locale de la Food and Drug Administration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apr\u00e8s avoir consult\u00e9 les organismes de r\u00e9glementation locaux, Roche a d\u00e9clar\u00e9 qu&#039;elle continuerait \u00e0 exp\u00e9dier le traitement aux patients ambulatoires dans d&#039;autres pays o\u00f9 il a \u00e9t\u00e9 approuv\u00e9. \u2013 Lire la suite : <a href=\"https:\/\/dmdwarrior.com\/fr\/sarepta-therapeutics-announces-pause-of-elevidys-shipments-in-the-usa\/\" target=\"_blank\" rel=\"noreferrer noopener\">Sarepta Therapeutics annonce la suspension des livraisons d&#039;ELEVIDYS aux \u00c9tats-Unis<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le Japon, le Br\u00e9sil, Isra\u00ebl, les \u00c9mirats arabes unis, le Qatar et le Kowe\u00eft font partie des pays qui ont approuv\u00e9 le Elevidys.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Selon la d\u00e9claration envoy\u00e9e par courriel par Roche, la suspension est temporaire et facultative pour tous les patients atteints de dystrophie musculaire de Duchenne, quelle que soit leur capacit\u00e9 \u00e0 marcher.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tard lundi, Sarepta a annonc\u00e9 qu&#039;elle se conformerait \u00e0 la demande du FDA d&#039;arr\u00eater toutes les exp\u00e9ditions du Elevidys aux \u00c9tats-Unis.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Suite au d\u00e9c\u00e8s de deux adolescents ayant re\u00e7u le Elevidys cette ann\u00e9e, Sarepta a annonc\u00e9 vendredi le d\u00e9c\u00e8s d&#039;un autre patient ayant b\u00e9n\u00e9fici\u00e9 de sa th\u00e9rapie g\u00e9nique exp\u00e9rimentale suite \u00e0 une insuffisance h\u00e9patique aigu\u00eb. Ce d\u00e9c\u00e8s a incit\u00e9 le FDA \u00e0 demander ce traitement.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche a d\u00e9clar\u00e9 qu&#039;elle \u00e9tait en communication avec les autorit\u00e9s sanitaires du monde entier pour d\u00e9terminer les prochaines \u00e9tapes possibles et qu&#039;elle tentait de d\u00e9terminer la raison derri\u00e8re la demande du FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En 2019, Roche a achet\u00e9 les droits commerciaux non am\u00e9ricains du Elevidys de Sarepta.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;\u00e9volution de la situation a \u00e9t\u00e9 initialement rapport\u00e9e par Bloomberg News.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apprendre encore plus: <a href=\"https:\/\/dmdwarrior.com\/fr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\">Questions fr\u00e9quemment pos\u00e9es sur Elevidys<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>According to the Swiss pharmaceutical company, the halt, which goes into effect on 22nd July 2025 covers new Elevidys orders in non-US nations that rely on local approval from the Food and Drug Administration. After consulting with local regulatory bodies, Roche stated that it will keep shipping the therapy to ambulatory patients in other nations [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4177,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[33,203,65],"class_list":["post-4175","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-elevidys","tag-roche","tag-sarepta"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4175","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=4175"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4175\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/4177"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=4175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=4175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=4175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}