{"id":4219,"date":"2025-07-25T14:33:50","date_gmt":"2025-07-25T11:33:50","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4219"},"modified":"2025-07-25T15:19:18","modified_gmt":"2025-07-25T12:19:18","slug":"brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec\/","title":{"rendered":"Brezilya, ELEVIDYS&#039;in (delandistrogene moxeparvovec) Kullan\u0131m\u0131n\u0131 Ask\u0131ya Ald\u0131"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Brezilya Sa\u011fl\u0131k D\u00fczenleme Kurumu (Anvisa), ihtiyati tedbir olarak gen terapisi ilac\u0131 Elevidys&#039;nin (delandistrogen moxeparvovek) Brezilya&#039;da pazarlamas\u0131n\u0131, da\u011f\u0131t\u0131m\u0131n\u0131, \u00fcretimini, ithalat\u0131n\u0131, reklam\u0131n\u0131 ve kullan\u0131m\u0131n\u0131 ge\u00e7ici olarak ask\u0131ya ald\u0131\u011f\u0131n\u0131 duyurdu. Ask\u0131ya alma, Amerika Birle\u015fik Devletleri&#039;nde \u00fcr\u00fcnle tedavi edilen hastalarda akut karaci\u011fer yetmezli\u011finin \u00f6l\u00fcmc\u00fcl vakalar\u0131yla ilgili son g\u00fcvenlik belirsizlikleri tamamen netle\u015fene kadar y\u00fcr\u00fcrl\u00fckte kalacakt\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu karar, ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA) taraf\u0131ndan yay\u0131nlanan ve Sarepta Therapeutics taraf\u0131ndan geli\u015ftirilen AAVrh74 vekt\u00f6r teknolojisini i\u00e7eren gen tedavisi \u00fcr\u00fcnlerinin kullan\u0131m\u0131yla ili\u015fkili \u00fc\u00e7 \u00f6l\u00fcm vakas\u0131n\u0131 bildiren yeni d\u00fczenleyici bilgilerin \u0131\u015f\u0131\u011f\u0131nda al\u0131nd\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130ki vaka, Elevidys ile tedavi edilen Duchenne Musk\u00fcler Distrofisi (DMD) olan y\u00fcr\u00fcyemeyen pediatrik hastalar\u0131, \u00fc\u00e7\u00fcnc\u00fc vaka ise ayn\u0131 viral vekt\u00f6re dayal\u0131 deneysel bir gen tedavisi \u00fcr\u00fcn\u00fc alan Limb-Girdle Musk\u00fcler Distrofisi olan yeti\u015fkin bir hastay\u0131 i\u00e7eriyordu. Her iki vaka da \u00f6l\u00fcmc\u00fcl sonu\u00e7lanan akut karaci\u011fer yetmezli\u011fine ilerlemeyi i\u00e7eriyordu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha fazla bilgi edin: <a href=\"https:\/\/dmdwarrior.com\/tr\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/\" target=\"_blank\" rel=\"noreferrer noopener\">Roche, Elevidys Gen Terapisinin ABD D\u0131\u015f\u0131na Sevkiyat\u0131n\u0131 Durdurdu<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha fazla bilgi edin: <a href=\"https:\/\/dmdwarrior.com\/tr\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/\" target=\"_blank\" data-type=\"post\" data-id=\"4222\" rel=\"noreferrer noopener\">Avrupa \u0130la\u00e7 Ajans\u0131 (EMA), Elevidys Hakk\u0131nda Olumsuz G\u00f6r\u00fc\u015f Bildirdi<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The Brazilian Health Regulatory Agency (Anvisa) announced that it has temporarily suspended the marketing, distribution, manufacturing, import, advertising, and use of the gene therapy drug Elevidys (delandistrogen moxeparvovek) in Brazil as a precautionary measure. The suspension will remain in effect until recent safety uncertainties related to fatal cases of acute liver failure in patients treated [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4220,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[180,82,121,33,179],"class_list":["post-4219","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-anvisa","tag-brazil","tag-delandistrogene-moxeparvovec","tag-elevidys","tag-elevidys-gene-therapy"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4219","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=4219"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4220"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}