{"id":2233,"date":"2026-09-20T11:02:15","date_gmt":"2026-09-20T08:02:15","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=2233"},"modified":"2026-09-20T11:11:13","modified_gmt":"2026-09-20T08:11:13","slug":"in-which-countries-is-elevidys-approved-is-elevidys-approved-in-europe","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/in-which-countries-is-elevidys-approved-is-elevidys-approved-in-europe\/","title":{"rendered":"Elevidys Hangi \u00dclkelerde Onayland\u0131? Elevidys Avrupa'da Onayland\u0131 m\u0131?"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Elevidys (delandistrogene moxeparvovec), Duchenne kas distrofisi (DMD) i\u00e7in geli\u015ftirilmi\u015f bir gen terapisidir. \u0130lk olarak Amerika Birle\u015fik Devletleri&#039;nde onaylanm\u0131\u015f ve daha sonra bir\u00e7ok ba\u015fka \u00fclkede de d\u00fczenleyici onaylar alm\u0131\u015ft\u0131r. Bununla birlikte, Elevidys \u015fu anda Avrupa Birli\u011fi&#039;nde onayl\u0131 de\u011fildir.<\/strong><\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#in-which-countries-is-elevidys-approved\">Elevidys Hangi \u00dclkelerde Onayland\u0131?<\/a><\/li><li><a href=\"#is-elevidys-approved-in-europe\">Elevidys Avrupa&#039;da onayl\u0131 m\u0131?<\/a><ul><li><a href=\"#what-does-the-ema-negative-opinion-mean\">EMA Olumsuz G\u00f6r\u00fc\u015f\u00fc Ne Anlama Geliyor?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 id=\"in-which-countries-is-elevidys-approved\" class=\"wp-block-heading\">Elevidys Hangi \u00dclkelerde Onayland\u0131?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2026 y\u0131l\u0131 itibar\u0131yla Elevidys, sekiz \u00fclkede onaylanm\u0131\u015ft\u0131r:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Amerika Birle\u015fik Devletleri<\/li>\n\n\n\n<li>Japonya<\/li>\n\n\n\n<li>\u0130srail<\/li>\n\n\n\n<li>Birle\u015fik Arap Emirlikleri<\/li>\n\n\n\n<li>Umman<\/li>\n\n\n\n<li>Bahreyn<\/li>\n\n\n\n<li>Katar<\/li>\n\n\n\n<li>Kuveyt<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1024x576.jpg\" alt=\"Elevidys, Amerika Birle\u015fik Devletleri, Japonya, \u0130srail, Birle\u015fik Arap Emirlikleri, Umman, Bahreyn, Katar ve Kuveyt dahil olmak \u00fczere 8 \u00fclkede onaylanm\u0131\u015ft\u0131r.\" class=\"wp-image-8752\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1024x576.jpg 1024w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-300x169.jpg 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-768x432.jpg 768w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1536x864.jpg 1536w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-18x10.jpg 18w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-746x420.jpg 746w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-150x84.jpg 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-696x392.jpg 696w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries-1068x601.jpg 1068w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/01\/elevidys-approved-countries.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Onaylanan ya\u015f aral\u0131\u011f\u0131, hareket kabiliyeti gereksinimleri ve di\u011fer uygunluk kriterleri \u00fclkeler aras\u0131nda farkl\u0131l\u0131k g\u00f6stermektedir. <strong>Amerika Birle\u015fik Devletleri'nde FDA, Elevidys'i halihaz\u0131rda, do\u011frulanm\u0131\u015f bir DMD mutasyonuna sahip, y\u00fcr\u00fcyebilen 4 ya\u015f ve \u00fczeri hastalar i\u00e7in endike etmektedir.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Japonya, Brezilya, \u0130srail ve K\u00f6rfez \u00fclkelerinin kendi ulusal d\u00fczenleyici gereklilikleri ve onaylanm\u0131\u015f endikasyonlar\u0131 vard\u0131r. Bu nedenle, bir \u00fclkede onay al\u0131nmas\u0131, hastan\u0131n ba\u015fka bir \u00fclkede de tedavi i\u00e7in uygun oldu\u011fu anlam\u0131na gelmez.<\/p>\n\n\n\n<h2 id=\"is-elevidys-approved-in-europe\" class=\"wp-block-heading\">Elevidys Avrupa&#039;da onayl\u0131 m\u0131?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Hay\u0131r. Elevidys, Avrupa Birli\u011fi'nde onaylanmam\u0131\u015ft\u0131r.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Avrupa \u0130la\u00e7 Ajans\u0131 (EMA), Roche&#039;un Elevidys i\u00e7in pazarlama izni ba\u015fvurusunu inceledi. <strong>24 Temmuz 2025 tarihinde, EMA \u0130nsan Kullan\u0131m\u0131na Y\u00f6nelik T\u0131bbi \u00dcr\u00fcnler Komitesi (CHMP) olumsuz g\u00f6r\u00fc\u015f bildirerek pazarlama izninin reddedilmesini tavsiye etti.<\/strong> Devam\u0131n\u0131 oku: <a href=\"https:\/\/dmdwarrior.com\/tr\/why-elevidys-was-not-approved-by-the-european-medicines-agency-ema\/\" target=\"_blank\" rel=\"noreferrer noopener\">Elevidys neden EMA taraf\u0131ndan onaylanmad\u0131?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EMA raporunda, temel \u00e7al\u0131\u015fman\u0131n 12 ay sonra North Star Ambulatory Assessment (NSAA) testinde plaseboya k\u0131yasla istatistiksel olarak anlaml\u0131 bir iyile\u015fme g\u00f6stermedi\u011fi belirtilmi\u015ftir. EMA raporunda ayr\u0131ca, g\u00f6zlemlenen distrofin ekspresyonunun hareket kabiliyetindeki bir iyile\u015fmeyle ili\u015fkilendirilemedi\u011fi de kaydedilmi\u015ftir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Bu, Elevidys'in \u015fu anda AB genelinde pazarlama iznine sahip olmad\u0131\u011f\u0131 anlam\u0131na gelir.<\/strong><\/p>\n\n\n\n<h3 id=\"what-does-the-ema-negative-opinion-mean\" class=\"wp-block-heading\">EMA Olumsuz G\u00f6r\u00fc\u015f\u00fc Ne Anlama Geliyor?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">EMA karar\u0131, Avrupa Birli\u011fi d\u00fczenleme s\u00fcrecine uygulan\u0131r. Di\u011fer \u00fclkelerdeki d\u00fczenleyici kurumlar taraf\u0131ndan verilen Elevidys onaylar\u0131n\u0131 iptal etmez.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Roche, Avrupa d\u00fczenleyici kurumlar\u0131yla g\u00f6r\u00fc\u015fmeleri s\u00fcrd\u00fcrmeyi ve Elevidys&#039;nin AB&#039;deki DMD hastalar\u0131na sunulmas\u0131na y\u00f6nelik potansiyel bir yolu ara\u015ft\u0131rmay\u0131 ama\u00e7lad\u0131\u011f\u0131n\u0131 belirtti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu nedenle aileler \u015funlar aras\u0131nda ayr\u0131m yapmal\u0131d\u0131r:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA'n\u0131n Amerika Birle\u015fik Devletleri'nde onay\u0131 \u2192 Evet<\/strong><br><strong>Di\u011fer bir\u00e7ok \u00fclkede onayland\u0131 \u2192 Evet<\/strong><br><strong>Avrupa Birli\u011fi\/EMA onay\u0131 \u2192 Olumsuz g\u00f6r\u00fc\u015f\u00fcn ard\u0131ndan hay\u0131r<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha fazla bilgi i\u00e7in: <a href=\"https:\/\/dmdwarrior.com\/tr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Elevidys S\u0131k\u00e7a Sorulan Sorular<\/strong><\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6nemli:<\/strong> D\u00fczenleyici onaylar ve tedaviye uygunluk ko\u015fullar\u0131 de\u011fi\u015febilir. Hastalar ve aileleri, mevcut durumu ve yerel uygunluk \u015fartlar\u0131n\u0131 kendi \u00fclkelerinin d\u00fczenleyici otoritesi ve nitelikli bir DMD uzman\u0131yla teyit etmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u015eimdi Ke\u015ffedin: <a href=\"https:\/\/dmdwarrior.com\/tr\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>DMDWarrior&#039;\u0131n DMD Klinik Ara\u015ft\u0131rmalar Merkezi<\/strong><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Elevidys (delandistrogene moxeparvovec) is a gene therapy developed for Duchenne muscular dystrophy (DMD). It was first approved in the United States and has subsequently received regulatory approvals in several other countries. However, Elevidys is not currently approved in the European Union. In Which Countries Is Elevidys Approved? As of 2026, Elevidys is approved in eight [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":8753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[95,33,91,84,61,910,142,94,96,93,65,92,79],"class_list":["post-2233","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-bahrain","tag-elevidys","tag-ema","tag-europe","tag-gene-therapy","tag-israel","tag-japan","tag-kuwait","tag-oman","tag-qatar","tag-sarepta","tag-united-arab-emirates","tag-usa"],"subtitle":"Elevidys hangi \u00fclkelerde onayland\u0131 ve hangi \u00fclkelerde DMD gen terapisine eri\u015febilir? En son Elevidys onayl\u0131 \u00fclkeleri inceleyin ve Elevidys'in Avrupa'da onayl\u0131 olup olmad\u0131\u011f\u0131n\u0131 \u00f6\u011frenin.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/2233","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\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=2233"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/2233\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/8753"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=2233"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=2233"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=2233"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}