{"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\/tr\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/","title":{"rendered":"Roche, Elevidys Gen Terapisinin ABD D\u0131\u015f\u0131na Sevkiyat\u0131n\u0131 Durdurdu"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0130svi\u00e7reli ila\u00e7 \u015firketine g\u00f6re, 22 Temmuz 2025&#039;te y\u00fcr\u00fcrl\u00fc\u011fe girecek olan durdurma, G\u0131da ve \u0130la\u00e7 Dairesi&#039;nin yerel onay\u0131na dayanan ABD d\u0131\u015f\u0131ndaki \u00fclkelerdeki yeni Elevidys sipari\u015flerini kaps\u0131yor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche, yerel d\u00fczenleyici kurumlarla yapt\u0131\u011f\u0131 g\u00f6r\u00fc\u015fmelerin ard\u0131ndan, tedavinin onayland\u0131\u011f\u0131 di\u011fer \u00fclkelerdeki ayaktan hastalara da g\u00f6nderilmeye devam edece\u011fini a\u00e7\u0131klad\u0131. \u2013 Devam\u0131n\u0131 Oku: <a href=\"https:\/\/dmdwarrior.com\/tr\/sarepta-therapeutics-announces-pause-of-elevidys-shipments-in-the-usa\/\" target=\"_blank\" rel=\"noreferrer noopener\">Sarepta Therapeutics, ABD&#039;de ELEVIDYS Sevkiyatlar\u0131n\u0131n Durdurulaca\u011f\u0131n\u0131 Duyurdu<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys&#039;yi onaylayan \u00fclkeler aras\u0131nda Japonya, Brezilya, \u0130srail, Birle\u015fik Arap Emirlikleri, Katar ve Kuveyt bulunuyor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche&#039;un e-postayla g\u00f6nderdi\u011fi a\u00e7\u0131klamaya g\u00f6re, Duchenne kas distrofisi olan t\u00fcm hastalar i\u00e7in ask\u0131ya alma i\u015flemi, y\u00fcr\u00fcme yetenekleri ne olursa olsun, ge\u00e7ici ve iste\u011fe ba\u011fl\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta, pazartesi g\u00fcn\u00fc ge\u00e7 saatlerde, FDA&#039;nin ABD i\u00e7indeki t\u00fcm Elevidys sevkiyatlar\u0131n\u0131n durdurulmas\u0131 talebine uyaca\u011f\u0131n\u0131 duyurdu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu y\u0131l Elevidys alan iki ergen \u00e7ocu\u011fun \u00f6l\u00fcm\u00fcn\u00fcn ard\u0131ndan, Sarepta Cuma g\u00fcn\u00fc deneysel gen tedavisi alan bir hastan\u0131n daha akut karaci\u011fer yetmezli\u011fi nedeniyle hayat\u0131n\u0131 kaybetti\u011fini duyurdu. Bu durum, FDA&#039;nin tedaviyi talep etmesine neden oldu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche, bundan sonraki olas\u0131 ad\u0131mlar\u0131 belirlemek i\u00e7in d\u00fcnya \u00e7ap\u0131ndaki sa\u011fl\u0131k otoriteleriyle ileti\u015fim halinde oldu\u011funu ve FDA&#039;nin talebinin arkas\u0131ndaki nedeni belirlemeye \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 belirtti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche, 2019 y\u0131l\u0131nda Sarepta&#039;n\u0131n Elevidys ilac\u0131n\u0131n ABD d\u0131\u015f\u0131ndaki ticari haklar\u0131n\u0131 sat\u0131n ald\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Geli\u015fme ilk olarak Bloomberg News taraf\u0131ndan duyuruldu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha fazla bilgi edin: <a href=\"https:\/\/dmdwarrior.com\/tr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\">Elevidys Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular<\/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"],"subtitle":"ABD'li orta\u011f\u0131 Sarepta Therapeutics'nin benzer bir hamlesini yans\u0131tan Roche, Sal\u0131 g\u00fcn\u00fc kas bozukluklar\u0131 i\u00e7in gen terapisi olan Elevidys'nin ABD d\u0131\u015f\u0131ndaki baz\u0131 \u00fclkelere sevkiyat\u0131n\u0131 ask\u0131ya ald\u0131\u011f\u0131n\u0131 duyurdu.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4175","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=4175"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4175\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4177"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}