{"id":2495,"date":"2026-08-24T13:02:00","date_gmt":"2026-08-24T10:02:00","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=2495"},"modified":"2026-09-19T13:01:07","modified_gmt":"2026-09-19T10:01:07","slug":"anvisa-cancels-elevidys-registration-brazil","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/anvisa-cancels-elevidys-registration-brazil\/","title":{"rendered":"ANVISA, Brezilya'da Elevidys'in Ruhsat\u0131n\u0131 \u0130ptal Etti"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Brezilya Ulusal Sa\u011fl\u0131k G\u00f6zetim Ajans\u0131 (ANVISA), Duchenne kas distrofisi (DMD) tedavisinde kullan\u0131lan bir gen terapisi olan Elevidys'in tescilini, mevcut etkinlik ve g\u00fcvenlik verilerinin kesin onay i\u00e7in yetersiz oldu\u011fu de\u011ferlendirmesinin ard\u0131ndan iptal etti.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Karar 24 A\u011fustos 2026'da a\u00e7\u0131kland\u0131. Brezilya Resmi Gazetesi'nde (DOU) yay\u0131mlanan iptal karar\u0131yla birlikte, Elevidys'in \u00fclkeye ithalat\u0131, da\u011f\u0131t\u0131m\u0131 ve ticarile\u015ftirilmesi resmen ask\u0131ya al\u0131nd\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys a\u015f\u0131s\u0131, Aral\u0131k 2024&#039;ten beri Brezilya&#039;da \u015fartl\u0131 onay alm\u0131\u015ft\u0131. Tedavi, ba\u011f\u0131ms\u0131z olarak y\u00fcr\u00fcyebilen ve uygulama i\u00e7in kullan\u0131lan viral vekt\u00f6re kar\u015f\u0131 \u00f6nceden antikorlar\u0131 bulunmayan, 4 ila 7 ya\u015f aras\u0131 Duchenne kas distrofisi olan \u00e7ocuklar i\u00e7in endikeydi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Rapora g\u00f6re, ANVISA&#039;n\u0131n karar\u0131, tedavinin etkinli\u011fi ve g\u00fcvenli\u011fiyle ilgili sunulan verilerin kesin onay i\u00e7in yetersiz oldu\u011fu de\u011ferlendirmesine dayan\u0131yordu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys, Brezilya&#039;n\u0131n Birle\u015fik Sa\u011fl\u0131k Sistemi&#039;ne (SUS) dahil edilmemi\u015ftir. Bunun yerine, tedavi \u00fclkede yasal s\u00fcre\u00e7ler yoluyla elde edilmi\u015f ve Duchenne kas distrofisi olan \u00e7ocuklarda gen terapisi olarak kullan\u0131lm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130ptalin ard\u0131ndan ANVISA, halihaz\u0131rda sat\u0131n alma veya tedavi alma s\u00fcrecine ba\u015flam\u0131\u015f olan hastalar\u0131 ilgilendiren vakalar\u0131n nas\u0131l ele al\u0131naca\u011f\u0131na karar verecektir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dolay\u0131s\u0131yla bu iptal, Elevidys'in Brezilya'daki d\u00fczenleyici stat\u00fcs\u00fcn\u00fc etkileyerek, ajans\u0131n mevcut etkinlik ve g\u00fcvenlik verilerini de\u011ferlendirmesinin ard\u0131ndan ithalat\u0131n\u0131, da\u011f\u0131t\u0131m\u0131n\u0131 ve ticarile\u015ftirilmesini ask\u0131ya almaktad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys, Duchenne kas distrofisi i\u00e7in kullan\u0131lan tek seferlik bir gen terapisidir. Brezilya&#039;da, \u00f6nceki onay\u0131, \u015fartl\u0131 onay\u0131 i\u00e7in belirlenen kriterler kapsam\u0131nda, bu rahats\u0131zl\u0131\u011fa sahip belirli bir \u00e7ocuk grubunu kaps\u0131yordu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Daha fazla bilgi edin:<\/strong> <a href=\"https:\/\/dmdwarrior.com\/tr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Elevidys Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Brazil\u2019s National Health Surveillance Agency (ANVISA) has cancelled the registration of Elevidys, a gene therapy used to treat Duchenne muscular dystrophy (DMD), following an assessment that the available efficacy and safety data were insufficient for definitive authorization. The decision was announced on August 24, 2026. With the cancellation published in Brazil\u2019s Official Gazette (DOU), the [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":2497,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[180,82,66,33,179,61,203,65],"class_list":["post-2495","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-anvisa","tag-brazil","tag-duchenne-muscular-dystrophy","tag-elevidys","tag-elevidys-gene-therapy","tag-gene-therapy","tag-roche","tag-sarepta"],"subtitle":"Brezilya, Elevidys gen tedavisinin tescilini iptal ederek bu DMD gen tedavisinin stat\u00fcs\u00fcn\u00fc de\u011fi\u015ftirdi. ANVISA'n\u0131n karar\u0131, Brezilya'daki ticarile\u015ftirilmesini ask\u0131ya ald\u0131.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/2495","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=2495"}],"version-history":[{"count":3,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/2495\/revisions"}],"predecessor-version":[{"id":8747,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/2495\/revisions\/8747"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/2497"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=2495"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=2495"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=2495"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}