{"id":4232,"date":"2025-07-26T16:10:18","date_gmt":"2025-07-26T13:10:18","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4232"},"modified":"2025-07-26T16:10:19","modified_gmt":"2025-07-26T13:10:19","slug":"fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/fda-investigating-death-of-8-year-old-brazilian-boy-who-received-elevidys\/","title":{"rendered":"FDA \u8c03\u67e5\u63a5\u53d7 Elevidys \u75ab\u82d7\u7684 8 \u5c81\u5df4\u897f\u7537\u5b69\u7684\u6b7b\u4ea1"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u6b63\u5728\u8c03\u67e5\u4e00\u540d 8 \u5c81\u7537\u5b69\u7684\u6b7b\u4ea1\u4e8b\u4ef6\uff0c\u8be5\u7537\u5b69\u63a5\u53d7\u4e86 Elevidys \u57fa\u56e0\u7597\u6cd5\uff08\u4e00\u79cd\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684 Sarepta Therapeutics \u57fa\u56e0\u7597\u6cd5\uff09\u3002\u8be5\u7537\u5b69\u4e8e 2025 \u5e74 6 \u6708 7 \u65e5\u6b7b\u4ea1\u3002FDA \u57fa\u56e0\u7597\u6cd5\u516c\u53f8\u5df2\u8bf7\u6c42\u5e76\u81ea\u613f\u6682\u505c\u4ea7\u54c1\u9500\u552e\uff0c\u4ee5\u8c03\u67e5\u5176\u5b89\u5168\u95ee\u9898\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u65b0\u95fb\u7a3f\uff0c\u5ba3\u5e03\u5bf9\u4e00\u540d\u63a5\u53d7ELEVIDYS\uff08delandistrogene moxeparvovec\uff09\u57fa\u56e0\u6cbb\u7597\u7684\u516b\u5c81\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08Duchenne\uff09\u60a3\u8005\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u5c55\u5f00\u8c03\u67e5\u3002 <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-investigating-death-8-year-old-boy-who-received-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u9605\u8bfb\u66f4\u591a<\/a> \u2013 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7f57\u6c0f\u5c1a\u672a\u63d0\u4f9b\u8be6\u7ec6\u4fe1\u606f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta \u8ba4\u4e3a\u6709\u5fc5\u8981\u5728 2025 \u5e74 7 \u6708 25 \u65e5\u5c31\u6b64\u95ee\u9898\u53d1\u8868\u58f0\u660e\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u60a3\u8005\u7684\u6b7b\u4ea1\u88ab\u8ba4\u4e3a\u4e0eELEVIDYS\u6cbb\u7597\u65e0\u5173\u3002\u6b63\u5982\u5f6d\u535a\u65b0\u95fb\u793eNaomi Kresge\u6628\u65e5\u62a5\u9053\u7684\u90a3\u6837\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7f57\u6c0f\u63a7\u80a1\u516c\u53f8\u8868\u793a\uff0c\u6700\u8fd1\u5df4\u897f\u4e00\u540d\u63a5\u53d7\u57fa\u56e0\u7597\u6cd5 Elevidys \u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u60a3\u8005\u6b7b\u4ea1\uff0c\u4f46\u8be5\u6b7b\u4ea1\u4e0e\u8be5\u7597\u6cd5\u65e0\u5173\u3002 <a href=\"https:\/\/investorrelations.sarepta.com\/news-releases\/news-release-details\/sarepta-therapeutics-provides-clarifying-statement-elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e ELEVIDYS \u7684\u58f0\u660e<\/a> \u2013 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7f57\u6c0f\u516c\u53f8\u5728\u58f0\u660e\u4e2d\u8868\u793a\uff0c\u8be5\u7537\u5b69\u5e76\u975e\u4e34\u5e8a\u8bd5\u9a8c\u53c2\u4e0e\u8005\uff1b\u62a5\u544a\u533b\u751f\u8ba4\u4e3a\u4ed6\u7684\u6b7b\u4ea1\u4e0e\u57fa\u56e0\u6cbb\u7597\u65e0\u5173<\/li>\n\n\n\n<li>\u6b7b\u4ea1\u62a5\u544a\u5df2\u62a5\u544a\u7ed9\u536b\u751f\u5f53\u5c40<\/li>\n\n\n\n<li><strong>\u7f57\u6c0f\u516c\u53f8\u5728\u7f8e\u56fd\u4ee5\u5916\u9500\u552e Sarepta \u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u6cbb\u7597\u836f\u7269 Elevidys\uff0c\u8be5\u516c\u53f8\u62d2\u7edd\u5c31\u8be5\u7537\u5b69\u7684\u5e74\u9f84\u6216\u75c5\u4f8b\u7ec6\u8282\u53d1\u8868\u8bc4\u8bba<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta \u4e8e 2025 \u5e74 6 \u6708 18 \u65e5\u901a\u8fc7 FDA \u7684\u4e0a\u5e02\u540e\u7535\u5b50\u6570\u636e\u5e93 FAERS \u5411 FDA \u62a5\u544a\u4e86\u6b64\u4e8b\u4ef6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/dmd-warriors-turkish-representative-shares-his-views-on-elevidys-gene-therapy-is-it-effective-and-why-is-it-expensive\/\" target=\"_blank\" rel=\"noreferrer noopener\">DMD WarrioR\u571f\u8033\u5176\u4ee3\u8868\u5206\u4eab\u5bf9Elevidys\u57fa\u56e0\u7597\u6cd5\u7684\u770b\u6cd5\uff1a\u5b83\u6709\u6548\u5417\uff1f\u4e3a\u4ec0\u4e48\u5b83\u5f88\u8d35\uff1f<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and voluntary suspension of product distribution as it investigates the safety concerns. The U.S. Food and Drug Administration [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4235,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,179,88,203,65],"class_list":["post-4232","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-elevidys-gene-therapy","tag-fda","tag-roche","tag-sarepta"],"subtitle":"FDA\u5ba3\u5e03\u5df2\u542f\u52a8Elevidys\u57fa\u56e0\u7597\u6cd5\u7684\u7814\u7a76\uff0c\u5e0c\u671b\u80fd\u591f\u6cbb\u6108\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u3002","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4232","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=4232"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4232\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4235"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4232"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}