{"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\/zh\/brazil-suspends-use-of-elevidys-delandistrogene-moxeparvovec\/","title":{"rendered":"\u5df4\u897f\u6682\u505c\u4f7f\u7528 ELEVIDYS\uff08delandistrogene moxeparvovec\uff09"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5df4\u897f\u536b\u751f\u76d1\u7ba1\u5c40\uff08Anvisa\uff09\u5ba3\u5e03\uff0c\u4f5c\u4e3a\u9884\u9632\u63aa\u65bd\uff0c\u5df2\u6682\u505c\u57fa\u56e0\u6cbb\u7597\u836f\u7269Elevidys\uff08delandistrogen moxeparvovek\uff09\u5728\u5df4\u897f\u7684\u8425\u9500\u3001\u5206\u9500\u3001\u751f\u4ea7\u3001\u8fdb\u53e3\u3001\u5e7f\u544a\u5ba3\u4f20\u548c\u4f7f\u7528\u3002\u8be5\u6682\u505c\u63aa\u65bd\u5c06\u6301\u7eed\u5230\u8fd1\u671f\u7f8e\u56fd\u4f7f\u7528\u8be5\u4ea7\u54c1\u6cbb\u7597\u7684\u60a3\u8005\u51fa\u73b0\u6025\u6027\u809d\u8870\u7aed\u6b7b\u4ea1\u75c5\u4f8b\u76f8\u5173\u7684\u5b89\u5168\u6027\u4e0d\u786e\u5b9a\u6027\u5f97\u5230\u5b8c\u5168\u6f84\u6e05\u4e3a\u6b62\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u4e00\u51b3\u5b9a\u662f\u6839\u636e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u7684\u65b0\u76d1\u7ba1\u4fe1\u606f\u505a\u51fa\u7684\uff0c\u8be5\u4fe1\u606f\u62a5\u544a\u4e86\u4e09\u8d77\u4e0e\u4f7f\u7528\u7531Sarepta Therapeutics\u5f00\u53d1\u7684AAVrh74\u8f7d\u4f53\u6280\u672f\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u6709\u5173\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e24\u4f8b\u75c5\u4f8b\u6d89\u53ca\u63a5\u53d7Elevidys\u6cbb\u7597\u7684\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u975e\u5367\u5e8a\u513f\u79d1\u60a3\u8005\uff0c\u7b2c\u4e09\u4f8b\u75c5\u4f8b\u6d89\u53ca\u4e00\u540d\u60a3\u6709\u80a2\u5e26\u578b\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u6210\u5e74\u60a3\u8005\uff0c\u8be5\u60a3\u8005\u6b63\u5728\u63a5\u53d7\u57fa\u4e8e\u540c\u4e00\u75c5\u6bd2\u8f7d\u4f53\u7684\u5728\u7814\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u3002\u4e24\u4f8b\u75c5\u4f8b\u5747\u8fdb\u5c55\u4e3a\u6025\u6027\u809d\u8870\u7aed\uff0c\u5e76\u5bfc\u81f4\u60a3\u8005\u6b7b\u4ea1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e86\u89e3\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u7f57\u6c0f\u6682\u505c\u5411\u7f8e\u56fd\u5883\u5916\u8fd0\u9001Elevidys\u57fa\u56e0\u7597\u6cd5<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e86\u89e3\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/\" target=\"_blank\" data-type=\"post\" data-id=\"4222\" rel=\"noreferrer noopener\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5bf9Elevidys\u53d1\u51fa\u8d1f\u9762\u610f\u89c1<\/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":"\u5728\u4e24\u540d DMD \u60a3\u8005\u548c\u4e00\u540d LGMD \u60a3\u8005\u6b7b\u4ea1\u540e\uff0c\u7f57\u6c0f\u516c\u53f8\u6682\u505c\u4e86 Elevidys \u7684\u56fd\u9645\u8fd0\u8f93\uff0c\u968f\u540e\u5df4\u897f\u536b\u751f\u76d1\u7ba1\u673a\u6784 (Anvisa) \u4e5f\u6682\u505c\u4e86 Elevidys \u7684\u4f7f\u7528\u3002","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/comments?post=4219"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4220"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4219"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}