{"id":4232,"date":"2025-07-26T16:10:18","date_gmt":"2025-07-26T13:10:18","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4232"},"modified":"2025-07-26T16:10:19","modified_gmt":"2025-07-26T13:10:19","slug":"fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys\/","title":{"rendered":"FDA, Elevidys Alan 8 Ya\u015f\u0131ndaki Brezilyal\u0131 \u00c7ocu\u011fun \u00d6l\u00fcm\u00fcn\u00fc Ara\u015ft\u0131r\u0131yor"},"content":{"rendered":"<p class=\"wp-block-paragraph\">ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA), Duchenne kas distrofisi i\u00e7in Sarepta Therapeutics gen tedavisi olan Elevidys alan 8 ya\u015f\u0131nda bir erkek \u00e7ocu\u011funun \u00f6l\u00fcm\u00fcn\u00fc ara\u015ft\u0131r\u0131yor. \u00d6l\u00fcm 7 Haziran 2025&#039;te meydana geldi. FDA, g\u00fcvenlik endi\u015felerini ara\u015ft\u0131r\u0131rken \u00fcr\u00fcn da\u011f\u0131t\u0131m\u0131n\u0131n g\u00f6n\u00fcll\u00fc olarak durdurulmas\u0131n\u0131 talep etti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA), ELEVIDYS (delandistrogene moxeparvovec) gen tedavisi g\u00f6ren sekiz ya\u015f\u0131ndaki Duchenne kas distrofisi (Duchenne) hastas\u0131n\u0131n \u00f6l\u00fcm\u00fcyle ilgili soru\u015fturma ba\u015flat\u0131ld\u0131\u011f\u0131n\u0131 duyuran bir bas\u0131n a\u00e7\u0131klamas\u0131 yay\u0131nlad\u0131. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-investigating-death-8-year-old-boy-who-received-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">Devam\u0131n\u0131 oku<\/a> \u2013 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Roche hen\u00fcz ayr\u0131nt\u0131l\u0131 bilgi vermedi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta, 25 Temmuz 2025&#039;te konuya ili\u015fkin bir a\u00e7\u0131klama yapma ihtiyac\u0131 hissetti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu hastan\u0131n \u00f6l\u00fcm\u00fcn\u00fcn ELEVIDYS tedavisiyle ilgisi olmad\u0131\u011f\u0131 de\u011ferlendirildi. Bloomberg News&#039;den Naomi Kresge&#039;nin d\u00fcn bildirdi\u011fine g\u00f6re:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche Holding AG, Brezilya&#039;da Duchenne kas distrofisi i\u00e7in Elevidys gen tedavisi g\u00f6ren bir hastan\u0131n yak\u0131n zamanda hayat\u0131n\u0131 kaybetmesinin tedaviyle ilgisi olmad\u0131\u011f\u0131n\u0131 a\u00e7\u0131klad\u0131. <a href=\"https:\/\/investorrelations.sarepta.com\/news-releases\/news-release-details\/sarepta-therapeutics-provides-clarifying-statement-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">ELEVIDYS Hakk\u0131nda A\u00e7\u0131klama<\/a> \u2013 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Roche a\u00e7\u0131klamas\u0131nda, \u00e7ocu\u011fun klinik deney kat\u0131l\u0131mc\u0131s\u0131 olmad\u0131\u011f\u0131n\u0131, raporlayan doktorun \u00f6l\u00fcm\u00fcn\u00fcn gen tedavisiyle ilgisi olmad\u0131\u011f\u0131n\u0131 belirtti\u011fini belirtti<\/li>\n\n\n\n<li>\u00d6l\u00fcm sa\u011fl\u0131k yetkililerine bildirildi<\/li>\n\n\n\n<li><strong>Sarepta&#039;n\u0131n Duchenne tedavisi Elevidys&#039;yi ABD d\u0131\u015f\u0131nda pazarlayan Roche, \u00e7ocu\u011fun ya\u015f\u0131 veya vakan\u0131n ayr\u0131nt\u0131lar\u0131 hakk\u0131nda yorum yapmay\u0131 reddediyor<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta bu olay\u0131 18 Haziran 2025 tarihinde FDA&#039;nin pazarlama sonras\u0131 elektronik veri taban\u0131 FAERS arac\u0131l\u0131\u011f\u0131yla FDA&#039;ye bildirdi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Devam\u0131n\u0131 oku: <a href=\"https:\/\/dmdwarrior.com\/tr\/dmd-warriors-turkish-representative-shares-his-views-on-elevidys-gene-therapy-is-it-effective-and-why-is-it-expensive\/\" target=\"_blank\" rel=\"noreferrer noopener\">DMD WarrioR&#039;un T\u00fcrkiye Temsilcisi Elevidys Gen Terapisi Hakk\u0131ndaki G\u00f6r\u00fc\u015flerini Payla\u015f\u0131yor: Etkili mi ve Neden Pahal\u0131?<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and voluntary suspension of product distribution as it investigates the safety concerns. The U.S. Food and Drug Administration [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4235,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,179,88,203,65],"class_list":["post-4232","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-elevidys-gene-therapy","tag-fda","tag-roche","tag-sarepta"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4232","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=4232"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4232\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4235"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}