{"id":4868,"date":"2025-10-22T23:42:29","date_gmt":"2025-10-22T20:42:29","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4868"},"modified":"2025-11-03T19:57:59","modified_gmt":"2025-11-03T16:57:59","slug":"givinostat-duvyzat-three-reported-deaths-dmd-patient","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/givinostat-duvyzat-three-reported-deaths-dmd-patient\/","title":{"rendered":"NorthStar Network \u5173\u4e8e Givinostat (Duvyzat) \u7684\u58f0\u660e"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u6839\u636e\u82f1\u56fd\u808c\u8089\u840e\u7f29\u75c7\u534f\u4f1a\u7f51\u7ad9\u7684\u516c\u544a\uff0cNorthStar Network\u8868\u793a\uff1a\u2018\u4f5c\u4e3a\u5bf9Givinostat\uff08Duvyzat\uff09\u5728\u73b0\u5b9e\u4e16\u754c\u4f7f\u7528\u548c\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u98ce\u9669\u72b6\u51b5\u7684\u6301\u7eed\u76d1\u6d4b\u7684\u4e00\u90e8\u5206\uff0c\u6211\u4eec\u6ce8\u610f\u5230\u5728\u5f00\u653e\u6807\u7b7e\u6269\u5c55\uff08OLE\uff09\u7814\u7a76\u4e2d\u51fa\u73b0\u4e86\u4e09\u4f8b\u731d\u6b7b\u75c5\u4f8b\u3002\u2019<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Italfarmaco \u8868\u793a\uff0c\u8fc4\u4eca\u4e3a\u6b62\u5c1a\u672a\u6536\u5230\u4e0e givinostat \u76f8\u5173\u7684\u6b7b\u4ea1\u62a5\u544a\u3002DMD \u60a3\u8005\u53ca\u5176\u5bb6\u5c5e\u6b63\u5728\u5411 Italfarmaco\u3001EMA \u548c FDA \u7d22\u53d6\u8be6\u7ec6\u4fe1\u606f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u636e\u62a5\u9053\uff0c\u6709\u4e09\u540d\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u4e14\u63a5\u53d7\u836f\u7269 givinostat (Duvyzat) \u6cbb\u7597\u7684\u60a3\u8005\u6b7b\u4ea1\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5df2\u62a5\u544a\u75c5\u4f8b\uff1a<\/strong> \u5f00\u653e\u6807\u7b7e\u6269\u5c55\u7814\u7a76\u4e2d\u6709\u4e24\u4eba\u6b7b\u4ea1\uff0c\u6269\u5c55\u51c6\u5165\u8ba1\u5212\u4e2d\u6709\u4e00\u4eba\u6b7b\u4ea1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6301\u7eed\u76d1\u6d4b\uff1a<\/strong> \u8be5\u516c\u53f8\u6b63\u5728\u7ee7\u7eed\u76d1\u6d4b\u8be5\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u98ce\u9669\u6548\u76ca\u72b6\u51b5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u66f4\u65b0\uff1a<\/strong> \u5982\u679c\u53d1\u73b0\u83b7\u76ca\u98ce\u9669\u6bd4\u53d1\u751f\u53d8\u5316\uff0c\u6211\u4eec\u5c06\u5206\u4eab\u66f4\u591a\u4fe1\u606f\u3002NorthStar Network \u5df2\u8868\u793a\u5c06\u63d0\u4f9b\u6700\u65b0\u4fe1\u606f\uff0c\u5e76\u9f13\u52b1\u5bb6\u5ead\u4e0e\u4e34\u5e8a\u56e2\u961f\u6c9f\u901a\uff0c\u5bfb\u6c42\u4e2a\u6027\u5316\u5efa\u8bae\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Update-on-Givinostat-for-families-22-October-2025-final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">NorthStar \u5173\u4e8e Givinostat \u7684\u58f0\u660e<\/a><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"916\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-1024x916.png\" alt=\"\u4e09\u540d\u63a5\u53d7 Givinostat Duvyzat \u6cbb\u7597\u7684 DMD \u60a3\u8005\u6b7b\u4ea1\" class=\"wp-image-4871\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-1024x916.png 1024w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-300x268.png 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-768x687.png 768w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-13x12.png 13w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-469x420.png 469w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-150x134.png 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-696x623.png 696w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132-1068x955.png 1068w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/10\/Screenshot-2025-10-22-230132.png 1291w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">NorthStar Network \u7684\u58f0\u660e<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6587\u4ef6\u7531 Michela Guglieri \u6559\u6388\u3001Anne-Marie Childs \u535a\u58eb\u3001Adnan Manzur \u535a\u58eb\u3001Tracey Willis \u6559\u6388\u548c Francesco Muntoni \u6559\u6388\u4ee3\u8868 NS Network \u7f16\u5199\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6211\u4eec\u6700\u8fd1\u83b7\u6089\uff0c\u63a5\u53d7 givinostat \u6cbb\u7597\u7684\u60a3\u6709 DMD \u7684\u513f\u7ae5\/\u5e74\u8f7b\u4eba\u4e2d\u53d1\u751f\u4e86 3 \u4f8b\u731d\u6b7b\u75c5\u4f8b\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Italfarmaco \u5df2\u6839\u636e\u76d1\u7ba1\u8981\u6c42\u5411\u5305\u62ec\u82f1\u56fd MHRA \u5728\u5185\u7684\u76d1\u7ba1\u673a\u6784\u62a5\u544a\u4e86\u8fd9\u4e09\u8d77\u75c5\u4f8b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2025 \u5e74 10 \u6708 20 \u65e5\uff0c\u751f\u4ea7 givinostat \u7684\u516c\u53f8 Italfarmaco \u9488\u5bf9\u6700\u8fd1\u62a5\u9053\u7684\u4f7f\u7528 givinostat \u6cbb\u7597\u7684 DMD \u60a3\u8005\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u5411\u60a3\u8005\u54a8\u8be2\u5c0f\u7ec4 (PAG) \u53d1\u5e03\u4e86\u4ee5\u4e0b\u4fe1\u606f\uff1a<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cGivinostat \u7684\u5b89\u5168\u6027\u57fa\u4e8e\u4e00\u9879\u4e3a\u671f 18 \u4e2a\u6708\u7684\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7814\u7a76\uff08EPIDYS \u7814\u7a76\uff09\uff0c\u8be5\u7814\u7a76\u5171\u7eb3\u5165\u4e86 179 \u540d 6 \u5c81\u53ca\u4ee5\u4e0a\u3001\u53ef\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u540c\u65f6\u63a5\u53d7\u7c7b\u56fa\u9187\u6cbb\u7597\u3002\u5728 EPIDYS \u8bd5\u9a8c\u671f\u95f4\uff0cGivinostat \u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u5747\u672a\u62a5\u544a\u6b7b\u4ea1\u75c5\u4f8b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u5df2\u6709\u8d85\u8fc7 1700 \u540d\u60a3\u8005\u5728\u4e34\u5e8a\u7814\u7a76\u3001\u6269\u5927\u83b7\u53d6\u8ba1\u5212\u548c\u5546\u4e1a\u73af\u5883\u4e2d\u63a5\u89e6\u8fc7 givinostat\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4f5c\u4e3a\u5bf9givinostat\u5728\u73b0\u5b9e\u4e16\u754c\u5e94\u7528\u548c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u83b7\u76ca\u98ce\u9669\u7279\u5f81\u6301\u7eed\u76d1\u6d4b\u7684\u4e00\u90e8\u5206\uff0c\u6211\u4eec\u83b7\u6089\u5f00\u653e\u6807\u7b7e\u6269\u5c55 (OLE) \u7814\u7a76\u4e2d\u53d1\u751f\u4e862\u4f8b\u731d\u6b7b\u75c5\u4f8b\uff0c\u5176\u4e2d1\u4f8b\u53d1\u751f\u5728\u8377\u5170\uff082025\u5e749\u6708\uff09\uff0c1\u4f8b\u53d1\u751f\u5728\u7f8e\u56fd\uff082024\u5e7410\u6708\uff09\u3002\u6211\u4eec\u8fd8\u83b7\u6089\uff0c\u5728\u5fb7\u56fd\u7684givinostat\u6269\u5c55\u83b7\u53d6\u8ba1\u5212\uff082025\u5e746\u6708\uff09\u4e2d\u53d1\u751f\u4e861\u4f8b\u731d\u6b7b\u75c5\u4f8b\u3002.<\/strong> \u5df2\u6839\u636e\u5f53\u5730\u6307\u5bfc\u65b9\u9488\uff08\u5305\u62ec\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u5c40 (MHRA)\uff09\u5411\u4e3b\u7ba1\u90e8\u95e8\u62a5\u544a\u4e86\u6b7b\u4ea1\u4e8b\u4ef6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fc4\u4eca\u4e3a\u6b62\uff0cItalfarmaco \u5df2\u8bc4\u4f30\u5c1a\u672a\u53d1\u73b0\u4e0e Givinostat \u76f8\u5173\u7684\u6b7b\u4ea1\u75c5\u4f8b\u3002\u56e0\u6b64\uff0c\u57fa\u4e8e\u76ee\u524d\u7684\u6570\u636e\uff0cGivinostat \u7684\u83b7\u76ca\u98ce\u9669\u6bd4\u4fdd\u6301\u4e0d\u53d8\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u98ce\u9669\u6536\u76ca\u72b6\u51b5\u53d1\u751f\u53d8\u5316\uff0c\u6211\u4eec\u5c06\u63d0\u9192\u533b\u751f\u3001\u793e\u533a\u5e76\u4e0e\u76d1\u7ba1\u673a\u6784\u8fdb\u884c\u9002\u5f53\u7684\u8054\u7edc\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9664\u975e\u83b7\u76ca\u98ce\u9669\u72b6\u51b5\u53d1\u751f\u53d8\u5316\uff0c\u5426\u5219\u6211\u4eec\u65e0\u6cd5\u63d0\u4f9b\u6301\u7eed\u66f4\u65b0\u3002\u51fa\u4e8e\u5bf9\u60a3\u8005\u9690\u79c1\u7684\u8003\u8651\uff0c\u6211\u4eec\u65e0\u6cd5\u4ee5\u4e66\u9762\u5f62\u5f0f\u5206\u4eab\u8fd9\u4e9b\u5177\u4f53\u75c5\u4f8b\u7684\u8be6\u7ec6\u4fe1\u606f\u3002\u201d<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f5c\u4e3a\u4e34\u5e8a\u533b\u751f\uff0c\u6211\u4eec\u4ec5\u83b7\u5f97\u4e86\u8fd9\u4e9b\u75c5\u4f8b\u60c5\u51b5\u7684\u6458\u8981\uff0c\u8fd9\u610f\u5473\u7740\u6211\u4eec\u5f88\u96be\u5b8c\u6210\u5168\u9762\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u76d1\u7ba1\u673a\u6784\uff08MHRA\uff09\u7684\u804c\u8d23\u662f\u8bc4\u4f30\u5728\u82f1\u56fd\u901a\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u3001EAP\u6216\u5e38\u89c4NHS\u62a4\u7406\u5f00\u5177\u7684\u4efb\u4f55\u836f\u7269\u7684\u98ce\u9669\u6548\u76ca\u300210\u670822\u65e5\uff0c\u6211\u4eec\u6536\u5230MHRA\u7684\u786e\u8ba4\uff0c\u4ed6\u4eec\u5df2\u6536\u5230\u4e0e\u8fd93\u4f8b\u75c5\u4f8b\u76f8\u5173\u7684\u4fe1\u606f\uff0c\u5e76\u5411\u6211\u4eec\u4fdd\u8bc1\u4ed6\u4eec\u6b63\u5728\u5feb\u901f\u8bc4\u4f30\u8fd9\u4e9b\u4fe1\u606f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u622a\u81f32025\u5e7410\u670822\u65e5\u7684\u73b0\u6709\u4fe1\u606f\uff0c\u6ca1\u6709\u660e\u786e\u8bc1\u636e\u8868\u660e\u8fd9\u4e9b\u6b7b\u4ea1\u4e0egivinostat\u6216\u5176\u5df2\u77e5\u7684\u526f\u4f5c\u7528\u76f4\u63a5\u76f8\u5173\u3002\u5176\u4ed6\u56e0\u7d20\uff0c\u5305\u62ec\u5408\u5e76\u75c7\u548c\u5408\u5e76\u7528\u836f\uff0c\u53ef\u80fd\u5728\u8fd9\u4e9b\u75c5\u4f8b\u4e2d\u53d1\u6325\u4e86\u4f5c\u7528\u3002\u4e3a\u4e86\u5e94\u5bf9\u8fd9\u4e9b\u4e8b\u4ef6\uff0c\u5e76\u5728\u7b49\u5f85MHRA\u63d0\u4f9b\u66f4\u591a\u4fe1\u606f\u7684\u540c\u65f6\uff0c\u6211\u4eec\u5c06\u7ee7\u7eed\u5bc6\u5207\u76d1\u6d4b\u548c\u8bc4\u4f30\u4efb\u4f55\u5373\u5c06\u5f00\u59cb\u6cbb\u7597\u548c\/\u6216\u5df2\u63a5\u53d7\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u4ee5\u786e\u4fdd\u5bf9givinostat\u6cbb\u7597\u7684\u98ce\u9669\u548c\u76ca\u5904\u8fdb\u884c\u4e2a\u4f53\u5316\u8bc4\u4f30\u3002\u6211\u4eec\u5c06\u5728\u83b7\u5f97\u4efb\u4f55\u8fdb\u4e00\u6b65\u4fe1\u606f\u540e\u53ca\u65f6\u5206\u4eab\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u9605\u8bfb\u66f4\u591a<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/zh\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u4e34\u5e8a\u8bd5\u9a8c\uff08\u6240\u6709\u7814\u7a76\u5217\u8868\uff09<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>According to an announcement on the Muscular Dystrophy UK website, NorthStar Network stated: &#8216;As part of ongoing surveillance of the risk profile of Givinostat (Duvyzat) in real-world use and clinical studies, we are aware of three cases of sudden death in the open-label extension (OLE) study.&#8217; Italfarmaco states that there have been no reported deaths [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4869,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[46,47,311,445],"class_list":["post-4868","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-duvyzat","tag-givinostat","tag-italfarmaco","tag-northstar-network"],"subtitle":"\u636e\u516c\u544a\uff0c\u4e09\u540d\u63a5\u53d7givinostat\uff08Duvyzat\uff09\u6cbb\u7597\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u6b7b\u4ea1\u3002.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4868","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=4868"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4868\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4869"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4868"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}