{"id":11488,"date":"2020-11-20T18:02:39","date_gmt":"2020-11-20T23:02:39","guid":{"rendered":"https:\/\/www.progeriaresearch.org\/?p=11488"},"modified":"2022-11-14T17:17:52","modified_gmt":"2022-11-14T22:17:52","slug":"fda-approval","status":"publish","type":"post","link":"https:\/\/www.progeriaresearch.org\/zh\/2020\/11\/20\/fda-approval\/","title":{"rendered":"\u8fd9\u4e00\u5929\u7ec8\u4e8e\u5230\u6765\u4e86\uff1aFDA \u6279\u51c6\u9996\u4e2a\u65e9\u8870\u75c7\u6cbb\u7597\u65b9\u6cd5\uff01"},"content":{"rendered":"<p>[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.16\u2033 global_colors_info=\u201d{}\u201d][et_pb_row _builder_version=\u201d4.16\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033 custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dFDA\u201d _builder_version=\u201d4.18.1\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d hover_enabled=\u201d0\u2033 global_colors_info=\u201d{}\u201d sticky_enabled=\u201d0\u2033]<\/p>\n<p style=\"font-weight: 400;\"><strong><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-11496 size-medium alignleft\" src=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page-169x300.jpg\" alt=\"\" width=\"169\" height=\"300\" srcset=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page-169x300.jpg 169w, https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page.jpg 300w\" sizes=\"(max-width: 169px) 100vw, 169px\" \/><\/strong>\u4ee4\u4eba\u632f\u594b\u7684\u6700\u65b0\u6d88\u606f\uff012020 \u5e74 11 \u6708 20 \u65e5\uff0cPRF 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\u5171\u540c\u534f\u8c03\uff0c\u7531\u52c7\u6562\u7684\u5b69\u5b50\u548c\u4ed6\u4eec\u7684\u5bb6\u4eba\u63d0\u4f9b\u652f\u6301\uff0c\u5e76\u7531\u60a8\uff08PRF \u51fa\u8272\u7684\u6350\u52a9\u8005\u793e\u533a\uff09\u63d0\u4f9b\u8d44\u91d1\u3002<\/p>\n<p>\u6211\u4eec\u8fd8\u611f\u8c22\u6ce2\u58eb\u987f\u513f\u7ae5\u533b\u9662\u3001\u5b69\u4e4b\u5b9d\u513f\u7ae5\u533b\u9662\u3001\u5e03\u83b1\u6839\u5987\u5973\u533b\u9662\u3001\u5e03\u6717\u5927\u5b66\u3001\u6ce2\u58eb\u987f\u5927\u5b66\u548c\u7f8e\u56fd\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\u7b49\u4e16\u754c\u4e00\u6d41\u7684\u65e9\u8870\u75c7\u7814\u7a76\u56e2\u961f\u3002\u5411 PRF \u652f\u6301\u7684\u4e34\u5e8a\u8bd5\u9a8c\u514d\u8d39\u63d0\u4f9b lonafarnib \u7684\u5236\u836f\u5408\u4f5c\u4f19\u4f34\u4e5f\u53d1\u6325\u4e86\u91cd\u8981\u4f5c\u7528\uff0c\u5176\u4e2d\u5305\u62ec Shering-Plough\u3001\u9ed8\u514b**\uff08\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u4ee5\u5916\u79f0\u4e3a MSD\uff09\u548c Eiger BioPharmaceuticals\uff0c\u4ed6\u4eec\u4e3a\u63a8\u52a8\u65e9\u8870\u75c7\u7814\u7a76\u8fdb\u5c55\u8fbe\u5230\u975e\u51e1\u7684\u65b0\u9ad8\u5ea6\u505a\u51fa\u4e86\u8d21\u732e\u3002<\/p>\n<p>\u6211\u4eec\u5728 Eiger \u7684\u5408\u4f5c\u4f19\u4f34\u81f4\u529b\u4e8e\u4e3a\u5168\u7403\u60a3\u6709\u65e9\u8870\u75c7\u548c\u52a0\u5de5\u7f3a\u9677\u578b\u65e9\u8870\u6837\u6838\u86cb\u767d\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u6301\u7eed\u83b7\u5f97 lonafarnib \u7684\u673a\u4f1a\uff0c\u5e76\u4e14\u4ed6\u4eec\u5df2\u7ecf\u5efa\u7acb\u4e86\u670d\u52a1\u6765\u652f\u6301\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u83b7\u5f97 lonafarnib <em>\u827e\u683c\u4e00\u7ad9\u5f0f\u533b\u7597\u670d\u52a1\uff0c <\/em>\u4ee5\u53ca\u901a\u8fc7 Eiger \u7684\u9488\u5bf9\u7f8e\u56fd\u4ee5\u5916\u60a3\u8005\u7684\u7ba1\u7406\u8bbf\u95ee\u8ba1\u5212\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u5bf9 lonafarnib \u7684\u5ba1\u67e5\u4ecd\u5728\u8fdb\u884c\u4e2d\uff0c\u9884\u8ba1 EMA \u5c06\u5728 2021 \u5e74\u4e0b\u534a\u5e74\u505a\u51fa\u6279\u51c6\u51b3\u5b9a\u3002<\/p>\n<p>\u611f\u8c22\u5927\u5bb6\u5bf9\u8fd9\u9879\u7814\u7a76\u7684\u652f\u6301\uff0c\u8ba9\u6211\u4eec\u8d70\u5230\u4e86\u8fd9\u4e00\u5173\u952e\u65f6\u523b\u3002\u4f60\u4eec\u7684\u6301\u7eed\u652f\u6301\u4e5f\u8ba9\u6211\u4eec\u80fd\u591f\u7ee7\u7eed\u52aa\u529b\uff0c\u4e3a\u8fd9\u4e9b\u4e0d\u5bfb\u5e38\u7684\u5b69\u5b50\u627e\u5230\u6cbb\u6108\u65b9\u6cd5\u3002<\/p>\n<p><strong>\u8fd9\u771f\u662f\u4e00\u4e2a\u975e\u51e1\u7684\u65b9\u5f0f\u6765\u5f00\u59cb\u5047\u671f\u5e76\u7ed3\u675f\u8fd9\u4e2a\u4ee4\u4eba\u96be\u4ee5\u7f6e\u4fe1\u7684<\/strong><strong> \u5177\u6709\u6311\u6218\u6027\u7684<\/strong> <strong>\u5e74\u3002<\/strong><\/p>\n<p><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/PRF-Press-Release-Zokinvy-FDA-Approval-FINAL.pdf\" rel=\"attachment wp-att-11508\">\u70b9\u51fb\u6b64\u5904\u67e5\u770b\u6211\u4eec\u7684\u65b0\u95fb\u7a3f<\/a> \u5176\u4e2d\u63d0\u4f9b\u4e86\u6709\u5173\u8fd9\u4e00\u5386\u53f2\u6027\u65b0\u95fb\u7684\u66f4\u591a\u8be6\u7ec6\u4fe1\u606f\u3002<\/p>\n<p>*300 \u79cd\u7f55\u89c1\u75be\u75c5\u6709 FDA \u6279\u51c6\u7684\u6cbb\u7597\u65b9\u6cd5\uff08<a href=\"https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000&amp;source=gmail&amp;ust=1617209033114000&amp;usg=AFQjCNGl8GC3JC7PBWSWbj-cHfQgWmhudQ\">https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000<\/a>\u00a0\u5df2\u77e5\u5206\u5b50\u57fa\u7840\u7684\u7f55\u89c1\u75be\u75c5\uff08<a href=\"http:\/\/www.omim.org\/\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=http:\/\/www.OMIM.org&amp;source=gmail&amp;ust=1617209033114000&amp;usg=AFQjCNG6pGE6IFhDHqW6SGpJ5A14AfU7ZA\">www.OMIM.org<\/a>) =4.2%<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u201d4.16\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033 custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dFDA\u201d _builder_version=\u201d4.16\u2033 text_font_size=\u201d13px\u201d background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d]<\/p>\n<p><span>**\u00a0<\/span><span>PRF \u8c28\u611f\u8c22 Schering-Plough \/ Merck \u7814\u53d1\u90e8\u95e8\u7684\u79d1\u5b66\u5bb6\u505a\u51fa\u7684\u91cd\u8981\u8d21\u732e\uff0c\u4ed6\u4eec\u652f\u6301<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>lonafarnib \u5728 HGPS \u4e34\u5e8a\u524d\u6a21\u578b\u4e2d\u7684\u8bc4\u4f30\u548c\u65e9\u8870\u75c7\u60a3\u8005\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u8fd9<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>\u7531 W. Robert Bishop\u3001John Piwinski\u3001Cecil Pickett \u548c Catherine Strader \u9886\u5bfc\u7684\u56e2\u961f\u652f\u6301\u836f\u4ee3\u52a8\u529b\u5b66\/\u836f\u6548\u5b66\u7814\u7a76\uff0c\u4f18\u5316\u836f\u7269\u914d\u65b9\uff0c\u5e76\u786e\u4fdd\u5728\u6574\u4e2a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u836f\u7269\u4f9b\u5e94\u5145\u8db3\u3002\u8be5\u56e2\u961f\u7684\u6210\u5458\u5305\u62ec\uff1aSusan Arbuck\u3001<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span><\/span><span>\u963f\u7279\u00b7\u8d1d\u7279\u68ee\u3001\u827e\u4f26\u00b7\u5e93\u73c0\u3001\u827e\u7c73\u8389\u00b7\u5f17\u5170\u514b\u3001\u5927\u536b\u00b7\u54c8\u91cc\u65af\u3001\u4e54\u6cbb\u5b89\u5a1c\u00b7\u54c8\u91cc\u65af\u3001<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>Paul Kirschmeier\u3001Ming Liu\u3001Jin-Keon Pai\u3001Robert Patton\u3001Paul Statkevich\u3001Greg Szpunar\u3001Bohdan Yaremko\u3001Paul Zavodny \u548c Yali Zhu\u3002<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"<p>\u6211\u4eec\u5f88\u9ad8\u5174\u5730\u5ba3\u5e03\uff0c\u4eca\u5929\u6211\u4eec\u5b8c\u6210\u4e86 PRF \u4f7f\u547d\u7684\u4e00\u4e2a\u91cd\u8981\u90e8\u5206\uff1a\u9996\u4e2a\u6cbb\u7597\u65e9\u8870\u75c7\u7684\u836f\u7269 lonafarnib \u5df2\u83b7\u5f97 FDA \u6279\u51c6\u3002 <\/p>","protected":false},"author":2,"featured_media":11491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[2,1],"tags":[],"class_list":["post-11488","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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property=\"og:site_name\" content=\"The Progeria Research Foundation\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/ProgeriaResearch\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-20T23:02:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T22:17:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/posthpFDA-e1607461962809.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"200\" \/>\n\t<meta property=\"og:image:height\" content=\"199\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Karen Betournay\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@Progeria\" \/>\n<meta name=\"twitter:site\" content=\"@Progeria\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Karen Betournay\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/\"},\"author\":{\"name\":\"Karen Betournay\",\"@id\":\"https:\/\/www.progeriaresearch.org\/ta\/#\/schema\/person\/2be6cec85c11aaef7a7602636c5b9946\"},\"headline\":\"The day has come: FDA approval for first-ever Progeria 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