{"id":4222,"date":"2025-07-25T14:46:11","date_gmt":"2025-07-25T11:46:11","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4222"},"modified":"2025-10-21T14:29:47","modified_gmt":"2025-10-21T11:29:47","slug":"the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/","title":{"rendered":"\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5bf9Elevidys\u53d1\u51fa\u8d1f\u9762\u610f\u89c1"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u7f57\u6c0f\u516c\u53f8\u4eca\u5929\u5ba3\u5e03\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a (CHMP) \u5bf9 Elevidys (delandistrogene moxeparvovec) \u7528\u4e8e\u6cbb\u7597 3 \u81f3 7 \u5c81\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u95e8\u8bca\u60a3\u8005\u7684\u6709\u6761\u4ef6\u4e0a\u5e02\u8bb8\u53ef (CMA) \u53d1\u8868\u4e86\u5426\u5b9a\u610f\u89c1\u3002 <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u9605\u8bfb\u66f4\u591a<\/a> \u2013 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9274\u4e8e DMD \u9886\u57df\u672a\u6ee1\u8db3\u7684\u9700\u6c42\u5f88\u9ad8\uff0c\u7f57\u6c0f\u8ba1\u5212\u7ee7\u7eed\u4e0e EMA \u5408\u4f5c\uff0c\u63a2\u7d22\u6f5c\u5728\u7684\u524d\u8fdb\u9053\u8def\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Elevidys\u4e3a\u4f55\u672a\u83b7\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u6279\u51c6\uff08EMA\uff09<\/strong><\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">\u62d2\u7edd\u7684\u4e3b\u8981\u539f\u56e0<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636eEMA\u7684\u516c\u5f00\u8bc4\u4f30\uff0c\u5177\u4f53\u539f\u56e0\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5728\u5173\u952e\u7814\u7a76\uff08\u63d0\u4ea4\u7684\u4e3b\u8981\u8bc1\u636e\uff09\u4e2d\uff0cElevidys\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u572812\u4e2a\u6708\u65f6\u7684\u8fd0\u52a8\u529f\u80fd\uff08\u4f7f\u7528\u5317\u6781\u661f\u95e8\u8bca\u8bc4\u4f30\u91cf\u8868\uff08NSAA\uff09\u6d4b\u91cf\uff09\u6ca1\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6539\u5584\u3002\u572834\u5206\u5236\u7684\u91cf\u8868\u4e2d\uff0c\u5dee\u5f02\u4ec5\u4e3a0.65\u5206\uff0cEMA\u5f97\u51fa\u7ed3\u8bba\u201c\u53ef\u80fd\u662f\u5076\u7136\u7684\u201d\u3002.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5c3d\u7ba1\u8be5\u7597\u6cd5\u8bf1\u5bfc\u4e86\u8f83\u77ed\u5f62\u5f0f\u7684\u808c\u8425\u517b\u4e0d\u826f\u86cb\u767d\u7684\u8868\u8fbe\uff0c\u4f46\u808c\u8425\u517b\u4e0d\u826f\u86cb\u767d\u7684\u8868\u8fbe\u6c34\u5e73\u65e0\u6cd5\u53ef\u9760\u5730\u4e0e\u8fd0\u52a8\u80fd\u529b\u7684\u663e\u8457\u6539\u5584\u8054\u7cfb\u8d77\u6765\u3002.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5373\u4f7f\u8003\u8651\u5230\u53cd\u5e94\u66f4\u597d\u7684\u60a3\u8005\u4e9a\u7ec4\uff0c\u8be5\u516c\u53f8\u4e5f\u65e0\u6cd5\u4ee4\u4eba\u4fe1\u670d\u5730\u8bc1\u660e\u8be5\u6cbb\u7597\u5bf9\u8fd9\u4e9b\u7fa4\u4f53\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u76ca\u5904\u3002.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7531\u4e8e\u8be5\u516c\u53f8\u5df2\u7533\u8bf7\u6709\u6761\u4ef6\u4e0a\u5e02\u8bb8\u53ef (CMA)\uff0cEMA \u9002\u7528\u7684\u6807\u51c6\u662f\u5fc5\u987b\u5b58\u5728\u79ef\u6781\u7684\u83b7\u76ca\u98ce\u9669\uff08\u5373\u83b7\u76ca\u8bc1\u636e+\u53ef\u63a7\u98ce\u9669\uff09\uff0c\u5e76\u6709\u4ee4\u4eba\u4fe1\u670d\u7684\u6570\u636e\u652f\u6301\u3002EMA \u7684\u7ed3\u8bba\u662f\uff0c\u5728\u6b64\u80cc\u666f\u4e0b\u83b7\u76ca\u5c1a\u672a\u5f97\u5230\u5145\u5206\u8bc1\u660e\uff0c\u56e0\u6b64\u62d2\u7edd\u4e86\u8be5\u8bb8\u53ef\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e86\u89e3\u66f4\u591a\uff1a&nbsp;<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>","protected":false},"excerpt":{"rendered":"<p>Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD). &#8211; Read More &#8211; Given the high unmet need [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4226,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[121,33,179,91,213],"class_list":["post-4222","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-delandistrogene-moxeparvovec","tag-elevidys","tag-elevidys-gene-therapy","tag-ema","tag-european-medicines-agency"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4222","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=4222"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4222\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4226"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4222"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4222"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4222"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}