{"id":3684,"date":"2025-04-14T12:28:50","date_gmt":"2025-04-14T09:28:50","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3684"},"modified":"2025-06-21T13:47:29","modified_gmt":"2025-06-21T10:47:29","slug":"duvyzat-givinostat-ema-approval","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/duvyzat-givinostat-ema-approval\/","title":{"rendered":"Givinostat EMA \u6279\u51c6\uff1aGivinostat (Duvyzat) \u662f\u5426\u83b7\u5f97 EMA \u6279\u51c6\uff1f"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Duvyzat\uff08Givinostat\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u548c\u82f1\u56fd\u7684\u76d1\u7ba1\u6279\u51c6\uff0c\u5e76\u5df2\u5b8c\u6210\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7684\u8bc4\u4f30\u3002EMA\u5df2\u5efa\u8bae\u5728\u6b27\u76df\uff08EU\uff09\u6388\u4e88Duvyzat\uff08givinostat\uff09\u6709\u6761\u4ef6\u4e0a\u5e02\u8bb8\u53ef\uff0c\u7528\u4e8e\u6cbb\u7597\u516d\u5c81\u4ee5\u4e0a\u80fd\u591f\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u60a3\u8005\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Duvyzat\uff08givinostat\uff09\u662f\u9996\u4e2a\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u975e\u753e\u4f53\u7c7b\u836f\u7269\uff0c\u4e8e 2024 \u5e74 3 \u6708\u83b7\u5f97 FDA \u6279\u51c6\u3002\u867d\u7136\u8fd9\u5bf9\u6240\u6709\u60a3\u8005\u53ca\u5176\u5bb6\u4eba\u6765\u8bf4\u90fd\u662f\u597d\u6d88\u606f\uff0c\u4f46\u7f8e\u56fd\u4ee5\u5916\u7684\u8bb8\u591a\u4eba\u60f3\u77e5\u9053\uff0c\u7528\u4e8e\u6cbb\u7597 DMD \u7684 givinostat \u4f55\u65f6\u4e5f\u4f1a\u5728\u4ed6\u4eec\u7684\u56fd\u5bb6\u83b7\u5f97\u6279\u51c6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u5efa\u8bae\u5728\u6b27\u76df\u6709\u6761\u4ef6\u5730\u6388\u6743 Duvyzat (givinostat) \u7528\u4e8e\u6cbb\u7597\u516d\u5c81\u53ca\u4ee5\u4e0a\u80fd\u591f\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD)\u3002Duvyzat \u662f\u4e00\u79cd\u4e0e\u76ae\u8d28\u7c7b\u56fa\u9187\u7597\u6cd5\u8054\u5408\u53e3\u670d\u7684\u6df7\u60ac\u6db2\u3002<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u76ee\u5f55<\/h2><nav><ul><li><a href=\"#what-is-givinostat-used-for\">Givinostat \u7684\u7528\u9014\u662f\u4ec0\u4e48\uff1f<\/a><\/li><li><a href=\"#how-does-givinostat-work\">Givinostat \u5982\u4f55\u8d77\u4f5c\u7528\uff1f<\/a><\/li><li><a href=\"#givinostat-ema-approval-status\">Givinostat EMA \u6279\u51c6\u72b6\u6001<\/a><\/li><li><a href=\"#when-will-givinostat-be-available-in-europe\">givinostat \u4ec0\u4e48\u65f6\u5019\u80fd\u5728\u6b27\u6d32\u4e0a\u5e02\uff1f<\/a><\/li><li><a href=\"#italfarmaco-and-medis-announce-exclusive-distribution\">Givinostat \u5c06\u5982\u4f55\u5728\u6b27\u6d32\u56fd\u5bb6\u5206\u9500\uff1f<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-givinostat-used-for\">Givinostat \u7684\u7528\u9014\u662f\u4ec0\u4e48\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u516d\u5c81\u4ee5\u4e0a\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u60a3\u8005\u53ef\u4ee5\u4f7f\u7528 duvyzat\uff08givinostat\uff09\u6cbb\u7597\u3002\u8be5\u836f\u7269\u7684\u751f\u4ea7\u5546 Italfarmaco \u8868\u793a\uff0cgivinostat \u4e5f\u53ef\u7528\u4e8e\u6cbb\u7597\u8d1d\u514b\u5c14\u578b\u808c\u8425\u517b\u4e0d\u826f\u75c7 (BMD)\uff0c\u56e0\u4e3a\u5b83\u5177\u6709\u72ec\u7279\u7684\u4f5c\u7528\u673a\u5236\u3002\u7136\u800c\uff0c\u8be5\u836f\u7269\u5c1a\u672a\u83b7\u5f97\u6279\u51c6\u7528\u4e8e\u6cbb\u7597 BMD\u3002<a href=\"https:\/\/dmdwarrior.com\/zh\/duvyzat-givinostat-nonsteroidal-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duvyzat (Givinostat) \u662f\u4ec0\u4e48\uff1f<\/a>)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"how-does-givinostat-work\">Givinostat \u5982\u4f55\u8d77\u4f5c\u7528\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Givinostat \u662f\u4e00\u79cd\u7ec4\u86cb\u767d\u53bb\u4e59\u9170\u5316\u9176 (HDAC) \u6291\u5236\u5242\u3002\u7ec4\u86cb\u767d\u53bb\u4e59\u9170\u5316\u9176 (HDAC) \u662f Givinostat \u6240\u6291\u5236\u7684\u4e00\u7c7b\u9176\u3002HDAC \u53ef\u6fc0\u6d3b\u548c\u6291\u5236\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u4e2d\u53ef\u80fd\u964d\u4f4e\u808c\u8089\u518d\u751f\u7684\u57fa\u56e0\u3002Givinostat \u901a\u8fc7\u963b\u65ad HDAC \u6765\u4fc3\u8fdb\u808c\u8089\u4fee\u590d\u3001\u4fc3\u8fdb\u808c\u7ea4\u7ef4\u518d\u751f\uff0c\u5e76\u51cf\u8f7b\u708e\u75c7\u548c\u7ea4\u7ef4\u5316\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"givinostat-ema-approval-status\">Givinostat EMA \u6279\u51c6\u72b6\u6001<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CHMP \u5efa\u8bae\u6b27\u76df\u4e8e 2025 \u5e74 4 \u6708 25 \u65e5\u6279\u51c6 Duvyzat \u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u3002\uff08<a href=\"https:\/\/dmdwarrior.com\/zh\/ema-recommends-eu-approval-for-duvyzat-givinostat-to-treat-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u9605\u8bfb\u66f4\u591a<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2025\u5e746\u67086\u65e5\uff0cItalfarmaco\u5ba3\u5e03\u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u5df2\u6388\u4e88\u65b0\u578b\u7ec4\u86cb\u767d\u53bb\u4e59\u9170\u5316\u9176\uff08HDAC\uff09\u6291\u5236\u5242Duvyzat\uff08givinostat\uff09\u6709\u6761\u4ef6\u4e0a\u5e02\u8bb8\u53ef\u3002<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"when-will-givinostat-be-available-in-europe\">givinostat \u4ec0\u4e48\u65f6\u5019\u80fd\u5728\u6b27\u6d32\u4e0a\u5e02\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CHMP \u91c7\u7eb3\u7684\u610f\u89c1\u662f Duvyzat \u8d70\u5411\u60a3\u8005\u53ef\u53ca\u6027\u7684\u4e00\u4e2a\u4e2d\u95f4\u6b65\u9aa4\u3002\u8be5\u610f\u89c1\u5c06\u63d0\u4ea4\u81f3\u6b27\u76df\u59d4\u5458\u4f1a\uff0c\u4ee5\u5c31\u5176\u5728\u6b27\u76df\u8303\u56f4\u5185\u7684\u4e0a\u5e02\u8bb8\u53ef\u505a\u51fa\u51b3\u5b9a\u3002\u4e00\u65e6\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5404\u6210\u5458\u56fd\u5c06\u6839\u636e\u8be5\u836f\u7269\u5728\u672c\u56fd\u56fd\u5bb6\u536b\u751f\u4f53\u7cfb\u4e2d\u7684\u6f5c\u5728\u4f5c\u7528\/\u7528\u9014\uff0c\u81ea\u884c\u51b3\u5b9a\u4ef7\u683c\u548c\u62a5\u9500\u4e8b\u5b9c\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"italfarmaco-and-medis-announce-exclusive-distribution\">Givinostat \u5c06\u5982\u4f55\u5728\u6b27\u6d32\u56fd\u5bb6\u5206\u9500\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e 2025 \u5e74 3 \u6708 18 \u65e5\u53d1\u5e03\u7684\u58f0\u660e\uff0cItalfarmaco \u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u836f\u7269 Givinostat (Duvyzat) \u5c06\u7531\u4e2d\u6b27\u548c\u4e1c\u6b27\u9876\u7ea7\u533b\u836f\u5546\u4e1a\u5316\u4f01\u4e1a Medis \u72ec\u5bb6\u7ecf\u9500\u3002<a href=\"https:\/\/dmdwarrior.com\/zh\/italfarmaco-and-medis-distribution-agreement-for-givinostat-in-17-central-and-eastern-european-countries\/\">\u9605\u8bfb\u66f4\u591a<\/a>)<\/p>","protected":false},"excerpt":{"rendered":"<p>Duvyzat (Givinostat) has received regulatory approval in the US and UK and has completed its evaluation by the European Medicines Agency (EMA). EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3690,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[46,91,84,213,47],"class_list":["post-3684","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-duvyzat","tag-ema","tag-europe","tag-european-medicines-agency","tag-givinostat"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3684","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=3684"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3684\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3690"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=3684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=3684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=3684"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}