{"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\/zh\/anvisa-cancels-elevidys-registration-brazil\/","title":{"rendered":"\u5df4\u897f\u56fd\u5bb6\u536b\u751f\u76d1\u7763\u5c40\u53d6\u6d88Elevidys\u5728\u5df4\u897f\u7684\u6ce8\u518c"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>\u5df4\u897f\u56fd\u5bb6\u536b\u751f\u76d1\u7763\u5c40 (ANVISA) \u53d6\u6d88\u4e86\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u57fa\u56e0\u7597\u6cd5 Elevidys \u7684\u6ce8\u518c\uff0c\u6b64\u524d\u8bc4\u4f30\u8ba4\u4e3a\uff0c\u73b0\u6709\u7597\u6548\u548c\u5b89\u5168\u6027\u6570\u636e\u4e0d\u8db3\u4ee5\u8fdb\u884c\u6700\u7ec8\u6388\u6743\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u51b3\u5b9a\u4e8e 2026 \u5e74 8 \u6708 24 \u65e5\u5ba3\u5e03\u3002\u968f\u7740\u5df4\u897f\u5b98\u65b9\u516c\u62a5 (DOU) \u4e0a\u53d1\u5e03\u7684\u53d6\u6d88\u516c\u544a\uff0cElevidys \u5728\u8be5\u56fd\u7684\u8fdb\u53e3\u3001\u5206\u9500\u548c\u9500\u552e\u6b63\u5f0f\u6682\u505c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys \u81ea 2024 \u5e74 12 \u6708\u8d77\u5728\u5df4\u897f\u83b7\u5f97\u6709\u6761\u4ef6\u6388\u6743\u3002\u8be5\u7597\u6cd5\u9002\u7528\u4e8e 4 \u81f3 7 \u5c81\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u4e14\u4ecd\u80fd\u72ec\u7acb\u884c\u8d70\uff0c\u5e76\u4e14\u4f53\u5185\u6ca1\u6709\u9488\u5bf9\u7528\u4e8e\u7ed9\u836f\u7684\u75c5\u6bd2\u8f7d\u4f53\u7684\u9884\u5148\u5b58\u5728\u7684\u6297\u4f53\u7684\u513f\u7ae5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u8be5\u62a5\u544a\uff0cANVISA \u7684\u51b3\u5b9a\u662f\u57fa\u4e8e\u5176\u8bc4\u4f30\uff0c\u5373\u63d0\u4ea4\u7684\u6709\u5173\u8be5\u7597\u6cd5\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u6570\u636e\u4e0d\u8db3\u4ee5\u652f\u6301\u6700\u7ec8\u6388\u6743\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys\u5e76\u672a\u7eb3\u5165\u5df4\u897f\u7edf\u4e00\u533b\u7597\u7cfb\u7edf\uff08SUS\uff09\u3002\u76f8\u53cd\uff0c\u8be5\u7597\u6cd5\u662f\u901a\u8fc7\u6cd5\u5f8b\u7a0b\u5e8f\u5728\u8be5\u56fd\u83b7\u5f97\u7684\uff0c\u5e76\u88ab\u7528\u4f5c\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u513f\u7684\u57fa\u56e0\u7597\u6cd5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u53d6\u6d88\u4e4b\u540e\uff0cANVISA \u4ecd\u5c06\u51b3\u5b9a\u5982\u4f55\u5904\u7406\u5df2\u7ecf\u5f00\u59cb\u8d2d\u4e70\u6216\u63a5\u53d7\u6cbb\u7597\u7684\u60a3\u8005\u7684\u6848\u4f8b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u56e0\u6b64\uff0c\u6b64\u6b21\u53d6\u6d88\u5f71\u54cd\u4e86 Elevidys \u5728\u5df4\u897f\u7684\u76d1\u7ba1\u5730\u4f4d\uff0c\u5728\u5df4\u897f\u76d1\u7ba1\u673a\u6784\u8bc4\u4f30\u4e86\u73b0\u6709\u7597\u6548\u548c\u5b89\u5168\u6027\u6570\u636e\u540e\uff0c\u6682\u505c\u4e86\u8be5\u836f\u7269\u7684\u8fdb\u53e3\u3001\u5206\u9500\u548c\u5546\u4e1a\u5316\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elevidys \u662f\u4e00\u79cd\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u4e00\u6b21\u6027\u57fa\u56e0\u7597\u6cd5\u3002\u5728\u5df4\u897f\uff0c\u5b83\u4e4b\u524d\u7684\u83b7\u6279\u4ec5\u6db5\u76d6\u7b26\u5408\u5176\u6709\u6761\u4ef6\u83b7\u6279\u6807\u51c6\u7684\u7279\u5b9a\u4eba\u7fa4\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e86\u89e3\u66f4\u591a\uff1a<\/strong> <a href=\"https:\/\/dmdwarrior.com\/zh\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e Elevidys \u7684\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/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":"\u5df4\u897f\u5df2\u64a4\u9500Elevidys\u7684\u6ce8\u518c\uff0c\u6539\u53d8\u4e86\u8fd9\u79cd\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u57fa\u56e0\u7597\u6cd5\u7684\u73b0\u72b6\u3002\u5df4\u897f\u56fd\u5bb6\u536b\u751f\u76d1\u7763\u5c40\uff08ANVISA\uff09\u7684\u51b3\u5b9a\u6682\u505c\u4e86\u8be5\u7597\u6cd5\u5728\u5df4\u897f\u7684\u5546\u4e1a\u5316\u3002.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/2495","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/comments?post=2495"}],"version-history":[{"count":3,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/2495\/revisions"}],"predecessor-version":[{"id":8747,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/2495\/revisions\/8747"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/2497"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=2495"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=2495"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=2495"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}