{"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"],"_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}]}}