{"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\/ru\/brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec\/","title":{"rendered":"\u0411\u0440\u0430\u0437\u0438\u043b\u0438\u044f \u043f\u0440\u0438\u043e\u0441\u0442\u0430\u043d\u0430\u0432\u043b\u0438\u0432\u0430\u0435\u0442 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430 \u042d\u041b\u0415\u0412\u0418\u0414\u0418\u0421 (\u0434\u0435\u043b\u0430\u043d\u0434\u0438\u0441\u0442\u0440\u043e\u0433\u0435\u043d \u043c\u043e\u043a\u0441\u0435\u043f\u0430\u0440\u0432\u043e\u0432\u0435\u043a)"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0411\u0440\u0430\u0437\u0438\u043b\u044c\u0441\u043a\u043e\u0435 \u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u043e \u043f\u043e \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u044e \u0437\u0434\u0440\u0430\u0432\u043e\u043e\u0445\u0440\u0430\u043d\u0435\u043d\u0438\u044f (Anvisa) \u043e\u0431\u044a\u044f\u0432\u0438\u043b\u043e \u043e \u0432\u0440\u0435\u043c\u0435\u043d\u043d\u043e\u043c \u043f\u0440\u0438\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u043b\u0435\u043d\u0438\u0438 \u043c\u0430\u0440\u043a\u0435\u0442\u0438\u043d\u0433\u0430, \u0440\u0430\u0441\u043f\u0440\u043e\u0441\u0442\u0440\u0430\u043d\u0435\u043d\u0438\u044f, \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430, \u0438\u043c\u043f\u043e\u0440\u0442\u0430, \u0440\u0435\u043a\u043b\u0430\u043c\u044b \u0438 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u044f \u0433\u0435\u043d\u043e\u0442\u0435\u0440\u0430\u043f\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430 Elevidys (\u0434\u0435\u043b\u0430\u043d\u0434\u0438\u0441\u0442\u0440\u043e\u0433\u0435\u043d \u043c\u043e\u043a\u0441\u0435\u043f\u0430\u0440\u0432\u043e\u0432\u0435\u043a) \u0432 \u0411\u0440\u0430\u0437\u0438\u043b\u0438\u0438 \u0432 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0435 \u043c\u0435\u0440\u044b \u043f\u0440\u0435\u0434\u043e\u0441\u0442\u043e\u0440\u043e\u0436\u043d\u043e\u0441\u0442\u0438. \u041f\u0440\u0438\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u043a\u0430 \u0431\u0443\u0434\u0435\u0442 \u0434\u0435\u0439\u0441\u0442\u0432\u043e\u0432\u0430\u0442\u044c \u0434\u043e \u0442\u0435\u0445 \u043f\u043e\u0440, \u043f\u043e\u043a\u0430 \u043d\u0435 \u0431\u0443\u0434\u0443\u0442 \u043f\u043e\u043b\u043d\u043e\u0441\u0442\u044c\u044e \u043f\u0440\u043e\u044f\u0441\u043d\u0435\u043d\u044b \u043d\u0435\u0434\u0430\u0432\u043d\u0438\u0435 \u043d\u0435\u043e\u043f\u0440\u0435\u0434\u0435\u043b\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0432 \u043e\u0442\u043d\u043e\u0448\u0435\u043d\u0438\u0438 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u0438 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430, \u0441\u0432\u044f\u0437\u0430\u043d\u043d\u044b\u0435 \u0441 \u043b\u0435\u0442\u0430\u043b\u044c\u043d\u044b\u043c\u0438 \u0441\u043b\u0443\u0447\u0430\u044f\u043c\u0438 \u043e\u0441\u0442\u0440\u043e\u0439 \u043f\u0435\u0447\u0435\u043d\u043e\u0447\u043d\u043e\u0439 \u043d\u0435\u0434\u043e\u0441\u0442\u0430\u0442\u043e\u0447\u043d\u043e\u0441\u0442\u0438 \u0443 \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u043e\u0432, \u043f\u043e\u043b\u0443\u0447\u0430\u0432\u0448\u0438\u0445 \u043b\u0435\u0447\u0435\u043d\u0438\u0435 \u044d\u0442\u0438\u043c \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u043c \u0432 \u0421\u0428\u0410.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u042d\u0442\u043e \u0440\u0435\u0448\u0435\u043d\u0438\u0435 \u0431\u044b\u043b\u043e \u043f\u0440\u0438\u043d\u044f\u0442\u043e \u0432 \u0441\u0432\u0435\u0442\u0435 \u043d\u043e\u0432\u043e\u0439 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u043e\u0439 \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u0438, \u043e\u043f\u0443\u0431\u043b\u0438\u043a\u043e\u0432\u0430\u043d\u043d\u043e\u0439 \u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435\u043c \u043f\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0437\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430\u043c\u0438 \u043f\u0438\u0442\u0430\u043d\u0438\u044f \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u043c\u0438 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430\u043c\u0438 \u0421\u0428\u0410 (FDA), \u0432 \u043a\u043e\u0442\u043e\u0440\u043e\u0439 \u0441\u043e\u043e\u0431\u0449\u0430\u0435\u0442\u0441\u044f \u043e \u0442\u0440\u0435\u0445 \u0441\u043c\u0435\u0440\u0442\u0435\u043b\u044c\u043d\u044b\u0445 \u0441\u043b\u0443\u0447\u0430\u044f\u0445, \u0441\u0432\u044f\u0437\u0430\u043d\u043d\u044b\u0445 \u0441 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435\u043c \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432 \u0433\u0435\u043d\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0441 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435\u043c \u0432\u0435\u043a\u0442\u043e\u0440\u043d\u043e\u0439 \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0438\u0438 AAVrh74, \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u0430\u043d\u043d\u043e\u0439 Sarepta Therapeutics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0414\u0432\u0430 \u0441\u043b\u0443\u0447\u0430\u044f \u043a\u0430\u0441\u0430\u043b\u0438\u0441\u044c \u043d\u0435\u0445\u043e\u0434\u044f\u0447\u0438\u0445 \u0434\u0435\u0442\u0435\u0439 \u0441 \u043c\u044b\u0448\u0435\u0447\u043d\u043e\u0439 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u0435\u0439 \u0414\u044e\u0448\u0435\u043d\u043d\u0430 (\u041c\u0414\u0414), \u043f\u0440\u043e\u0445\u043e\u0434\u0438\u0432\u0448\u0438\u0445 \u043b\u0435\u0447\u0435\u043d\u0438\u0435 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u043c Elevidys, \u0430 \u0442\u0440\u0435\u0442\u0438\u0439 \u0441\u043b\u0443\u0447\u0430\u0439 \u043a\u0430\u0441\u0430\u043b\u0441\u044f \u0432\u0437\u0440\u043e\u0441\u043b\u043e\u0433\u043e \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0430 \u0441 \u043a\u043e\u043d\u0435\u0447\u043d\u043e\u0441\u0442\u043d\u043e-\u043f\u043e\u044f\u0441\u043d\u043e\u0439 \u043c\u044b\u0448\u0435\u0447\u043d\u043e\u0439 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u0435\u0439, \u043f\u043e\u043b\u0443\u0447\u0430\u0432\u0448\u0435\u0433\u043e \u044d\u043a\u0441\u043f\u0435\u0440\u0438\u043c\u0435\u043d\u0442\u0430\u043b\u044c\u043d\u044b\u0439 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442 \u0433\u0435\u043d\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u043d\u0430 \u043e\u0441\u043d\u043e\u0432\u0435 \u0442\u043e\u0433\u043e \u0436\u0435 \u0432\u0438\u0440\u0443\u0441\u043d\u043e\u0433\u043e \u0432\u0435\u043a\u0442\u043e\u0440\u0430. \u0412 \u043e\u0431\u043e\u0438\u0445 \u0441\u043b\u0443\u0447\u0430\u044f\u0445 \u043d\u0430\u0431\u043b\u044e\u0434\u0430\u043b\u043e\u0441\u044c \u043f\u0440\u043e\u0433\u0440\u0435\u0441\u0441\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435 \u043e\u0441\u0442\u0440\u043e\u0439 \u043f\u0435\u0447\u0451\u043d\u043e\u0447\u043d\u043e\u0439 \u043d\u0435\u0434\u043e\u0441\u0442\u0430\u0442\u043e\u0447\u043d\u043e\u0441\u0442\u0438 \u0441 \u043b\u0435\u0442\u0430\u043b\u044c\u043d\u044b\u043c \u0438\u0441\u0445\u043e\u0434\u043e\u043c.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0423\u0437\u043d\u0430\u0442\u044c \u0431\u043e\u043b\u044c\u0448\u0435: <a href=\"https:\/\/dmdwarrior.com\/ru\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/\" target=\"_blank\" rel=\"noreferrer noopener\">Roche \u043f\u0440\u0438\u043e\u0441\u0442\u0430\u043d\u0430\u0432\u043b\u0438\u0432\u0430\u0435\u0442 \u043f\u043e\u0441\u0442\u0430\u0432\u043a\u0438 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430 \u0434\u043b\u044f \u0433\u0435\u043d\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 Elevidys \u0437\u0430 \u043f\u0440\u0435\u0434\u0435\u043b\u044b \u0421\u0428\u0410<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0423\u0437\u043d\u0430\u0442\u044c \u0431\u043e\u043b\u044c\u0448\u0435: <a href=\"https:\/\/dmdwarrior.com\/ru\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/\" target=\"_blank\" data-type=\"post\" data-id=\"4222\" rel=\"noreferrer noopener\">\u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u043e\u0435 \u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u043e \u043f\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u043c \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430\u043c (EMA) \u0432\u044b\u043d\u0435\u0441\u043b\u043e \u043e\u0442\u0440\u0438\u0446\u0430\u0442\u0435\u043b\u044c\u043d\u043e\u0435 \u0437\u0430\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0435 \u043f\u043e Elevidys<\/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"],"subtitle":"\u041f\u043e\u0441\u043b\u0435 \u0442\u043e\u0433\u043e \u043a\u0430\u043a \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u044f Roche \u043f\u0440\u0435\u043a\u0440\u0430\u0442\u0438\u043b\u0430 \u043c\u0435\u0436\u0434\u0443\u043d\u0430\u0440\u043e\u0434\u043d\u044b\u0435 \u043f\u043e\u0441\u0442\u0430\u0432\u043a\u0438 Elevidys \u043f\u043e\u0441\u043b\u0435 \u0441\u043c\u0435\u0440\u0442\u0438 \u0434\u0432\u0443\u0445 \u0447\u0435\u043b\u043e\u0432\u0435\u043a \u0441 \u041c\u0414\u0414 \u0438 \u043e\u0434\u043d\u043e\u0433\u043e \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430 \u0441 \u041f\u041a\u041c\u0414, \u0411\u0440\u0430\u0437\u0438\u043b\u044c\u0441\u043a\u043e\u0435 \u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u043e \u043f\u043e \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u044e \u0437\u0434\u0440\u0430\u0432\u043e\u043e\u0445\u0440\u0430\u043d\u0435\u043d\u0438\u044f (Anvisa) \u0432\u0440\u0435\u043c\u0435\u043d\u043d\u043e \u043f\u0440\u0438\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0438\u043b\u043e \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435 Elevidys.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts\/4219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/comments?post=4219"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts\/4219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/media\/4220"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/media?parent=4219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/categories?post=4219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/tags?post=4219"}],"curies":[{"name":"WP","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}