{"id":4108,"date":"2025-07-16T10:53:45","date_gmt":"2025-07-16T07:53:45","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4108"},"modified":"2025-07-16T10:53:47","modified_gmt":"2025-07-16T07:53:47","slug":"sarepta-therapeutics-halts-elevidys-shipments-for-non-ambulatory-dmd-patients","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/sarepta-therapeutics-halts-elevidys-shipments-for-non-ambulatory-dmd-patients\/","title":{"rendered":"Sarepta Therapeutics, Y\u00fcr\u00fcyemeyen DMD Hastalar\u0131 \u0130\u00e7in ELEVIDYS Sevkiyatlar\u0131n\u0131 Durdurdu"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u00d6l\u00fcmle sonu\u00e7lanan iki ciddi karaci\u011fer yetmezli\u011fi vakas\u0131n\u0131n belgelenmesi nedeniyle Sarepta Therapeutics, y\u00fcr\u00fcyemeyen Duchenne kas distrofisi olan bireyler i\u00e7in gen tedavisi ELEVIDYS&#039;in g\u00f6nderimini durdurdu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En son hayat\u0131n\u0131 kaybeden hasta 15 ya\u015f\u0131ndayd\u0131. Protokol de\u011fi\u015fiklikleri ve d\u00fczenleyici hususlar g\u00f6z \u00f6n\u00fcnde bulundurularak, Sarepta, yeti\u015fkin ayakta tedavi g\u00f6ren ve y\u00fcr\u00fcyemeyen yeti\u015fkinleri kapsayan ENVISION Faz 3 do\u011frulama \u00e7al\u0131\u015fmas\u0131n\u0131 (SRP-9001-303) bu ciddi yan etkiler nedeniyle durdurmaya karar verdi. <strong>Devam\u0131n\u0131 oku<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/tr\/three-ongoing-clinical-trials-of-elevidys-gene-therapy-temporarily-halted-in-europe\/\">Avrupa&#039;da Elevidys Gen Terapisinin Devam Eden \u00dc\u00e7 Klinik \u00c7al\u0131\u015fmas\u0131 Ge\u00e7ici Olarak Durduruldu<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130ki \u00f6l\u00fcmc\u00fcl vaka Haziran 2025&#039;te bildirilmi\u015f ve FDA, ELEVIDYS ile ili\u015fkili akut karaci\u011fer yetmezli\u011fi riskini ara\u015ft\u0131rmak i\u00e7in 24 Haziran 2025&#039;te bir g\u00fcvenlik bildirimi yay\u0131nlam\u0131\u015ft\u0131r. Buna yan\u0131t olarak Sarepta, protokolleri g\u00fcncellemek ve d\u00fczenleyicilerle g\u00f6r\u00fc\u015fmek amac\u0131yla ENVISION Faz 3 \u00e7al\u0131\u015fmas\u0131n\u0131 durdurmu\u015ftur. \u015eirket ayr\u0131ca, yeni bir imm\u00fcnos\u00fcpresif tedavi rejimi onaylanana kadar ELEVIDYS&#039;in y\u00fcr\u00fcyemeyen hastalara da\u011f\u0131t\u0131m\u0131n\u0131 ge\u00e7ici olarak durdurmu\u015ftur.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Daha fazla bilgi edin<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/tr\/aan-report-reviews-the-state-of-evidence-on-elevidys-gene-therapy-cure-for-duchenne-muscular-dystrophy\/\">\u0130kinci Hasta \u00d6l\u00fcm\u00fcnden Sonra Duchenne Musk\u00fcler Distrofi Topluluklar\u0131 Elevidys Gen Terapisi Hakk\u0131nda Cevap \u0130stiyor<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Due to two documented incidents of severe liver failure that resulted in death, Sarepta Therapeutics has stopped shipping its gene treatment ELEVIDYS for individuals with non-ambulatory Duchenne muscular dystrophy. The patient who died most recently was 15 years old. In order to allow for protocol changes and regulatory considerations, Sarepta has decided to halt the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4109,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,65],"class_list":["post-4108","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-sarepta"],"subtitle":"Sarepta, ilac\u0131n tedavisi sonras\u0131nda akut karaci\u011fer yetmezli\u011fi ya\u015fayan iki hastan\u0131n \u00f6l\u00fcm\u00fcn\u00fcn bildirilmesinin ard\u0131ndan, y\u00fcr\u00fcyemeyen Duchenne kas distrofisi (DMD) hastalar\u0131na y\u00f6nelik ELEVIDYS sevkiyat\u0131n\u0131 ge\u00e7ici olarak durdurdu.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4108","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=4108"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4108\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4109"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4108"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}