{"id":9148,"date":"2019-12-18T18:01:35","date_gmt":"2019-12-18T18:01:35","guid":{"rendered":"https:\/\/www.progeriaresearch.org\/?p=9148"},"modified":"2020-03-23T15:03:20","modified_gmt":"2020-03-23T15:03:20","slug":"breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun","status":"publish","type":"post","link":"https:\/\/www.progeriaresearch.org\/uk\/2019\/12\/18\/breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun\/","title":{"rendered":"\u0420\u043e\u0437\u043f\u043e\u0447\u0430\u0442\u043e \u043f\u043e\u0434\u0430\u0447\u0443 \u0437\u0430\u044f\u0432\u043a\u0438 \u0434\u043e FDA \u043d\u0430 \u0441\u0445\u0432\u0430\u043b\u0435\u043d\u043d\u044f \u043b\u043e\u043d\u0430\u0444\u0430\u0440\u043d\u0456\u0431\u0443!"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243;][et_pb_row _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.27.4&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;]We\u2019re thrilled to announce a milestone in our mission to treat and cure children with Progeria: In partnership with The Progeria Research Foundation, Eiger BioPharmaceuticals has submitted to the FDA the first part of its application seeking approval of the drug lonafarnib as a treatment for Progeria.<\/p>\n<p>\u0426\u0435 \u043f\u0435\u0440\u0448\u0435 \u0432 \u0456\u0441\u0442\u043e\u0440\u0456\u0457 \u043f\u043e\u0434\u0430\u043d\u043d\u044f \u0454 \u043a\u0443\u043b\u044c\u043c\u0456\u043d\u0430\u0446\u0456\u0454\u044e \u0434\u0432\u0430\u043d\u0430\u0434\u0446\u044f\u0442\u044c\u043e\u0445 \u0440\u043e\u043a\u0456\u0432 \u0434\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u044c \u0456 \u0447\u043e\u0442\u0438\u0440\u044c\u043e\u0445 \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u044c, \u0444\u0456\u043d\u0430\u043d\u0441\u043e\u0432\u0430\u043d\u0438\u0445 PRF \u0443 \u043f\u0430\u0440\u0442\u043d\u0435\u0440\u0441\u0442\u0432\u0456 \u0437 \u0423\u043d\u0456\u0432\u0435\u0440\u0441\u0438\u0442\u0435\u0442\u043e\u043c \u0411\u0440\u0430\u0443\u043d\u0430 \u0442\u0430 \u0411\u043e\u0441\u0442\u043e\u043d\u0441\u044c\u043a\u043e\u044e \u0434\u0438\u0442\u044f\u0447\u043e\u044e \u043b\u0456\u043a\u0430\u0440\u043d\u0435\u044e, \u0449\u043e \u0441\u0442\u0430\u043b\u043e \u043c\u043e\u0436\u043b\u0438\u0432\u0438\u043c \u0437\u0430\u0432\u0434\u044f\u043a\u0438 \u0441\u043c\u0456\u043b\u0438\u0432\u0438\u043c \u0434\u0456\u0442\u044f\u043c \u0442\u0430 \u0457\u0445\u043d\u0456\u043c \u0440\u043e\u0434\u0438\u043d\u0430\u043c, \u0430 \u0442\u0430\u043a\u043e\u0436 \u0412\u0410\u041c \u2013 \u0447\u0443\u0434\u043e\u0432\u0456\u0439 \u0441\u043f\u0456\u043b\u044c\u043d\u043e\u0442\u0456 PRF. \u0434\u043e\u043d\u043e\u0440\u0456\u0432.<\/p>\n<p>\u0412\u0438 \u043c\u043e\u0436\u0435\u0442\u0435 \u043f\u0440\u043e\u0447\u0438\u0442\u0430\u0442\u0438 \u0431\u0456\u043b\u044c\u0448\u0435 \u043f\u0440\u043e \u0446\u044e \u0437\u0430\u0445\u043e\u043f\u043b\u044e\u044e\u0447\u0443 \u043d\u043e\u0432\u0438\u043d\u0443 <strong><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/PRF-Lonafarnib-NDA-Submission-Press-Release-FINAL-12-16-19.pdf\">\u0442\u0443\u0442<\/a><\/strong>.<\/p>\n<p>Eiger BioPharmaceuticals \u043f\u043e\u0441\u0442\u0456\u0439\u043d\u043e \u043f\u043e\u0434\u0430\u0432\u0430\u0442\u0438\u043c\u0435 \u0437\u0430\u0432\u0435\u0440\u0448\u0435\u043d\u0456 \u0447\u0430\u0441\u0442\u0438\u043d\u0438 \u0437\u0430\u044f\u0432\u043a\u0438 \u043d\u0430 \u0440\u043e\u0437\u0433\u043b\u044f\u0434 FDA, \u043f\u043b\u0430\u043d\u0443\u044e\u0447\u0438 \u0437\u0430\u0432\u0435\u0440\u0448\u0438\u0442\u0438 \u043f\u043e\u0434\u0430\u043d\u043d\u044f \u0432 \u043f\u0435\u0440\u0448\u043e\u043c\u0443 \u043a\u0432\u0430\u0440\u0442\u0430\u043b\u0456 \u043d\u043e\u0432\u043e\u0433\u043e \u0440\u043e\u043a\u0443. \u0421\u0445\u0432\u0430\u043b\u0435\u043d\u043d\u044f \u0434\u0430\u0441\u0442\u044c \u0437\u043c\u043e\u0433\u0443 \u0446\u0438\u043c \u0434\u0456\u0442\u044f\u043c \u0456 \u043c\u043e\u043b\u043e\u0434\u0438\u043c \u0434\u043e\u0440\u043e\u0441\u043b\u0438\u043c \u043e\u0442\u0440\u0438\u043c\u0430\u0442\u0438 \u0434\u043e\u0441\u0442\u0443\u043f \u0434\u043e \u043b\u043e\u043d\u0430\u0444\u0430\u0440\u043d\u0456\u0431\u0443 \u2013 \u044f\u043a\u0438\u0439, \u044f\u043a \u0431\u0443\u043b\u043e \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u043e, \u0437\u043c\u0456\u0446\u043d\u044e\u0454 \u0457\u0445 \u0441\u0435\u0440\u0446\u0435 \u0456 \u043f\u0440\u043e\u0434\u043e\u0432\u0436\u0443\u0454 \u0436\u0438\u0442\u0442\u044f \u2013 \u0437\u0430 \u0440\u0435\u0446\u0435\u043f\u0442\u043e\u043c, \u0430 \u043d\u0435 \u0447\u0435\u0440\u0435\u0437 \u043d\u0430\u0448\u0456 \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0456 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f, \u0443 \u0421\u0428\u0410 \u0442\u0430, \u043c\u043e\u0436\u043b\u0438\u0432\u043e, \u0442\u0430\u043a\u043e\u0436 \u0432 \u0456\u043d\u0448\u0438\u0445 \u043a\u0440\u0430\u0457\u043d\u0430\u0445.<\/p>\n<p><strong>\u042f\u043a\u0438\u0439 \u043f\u043e\u0437\u0438\u0442\u0438\u0432\u043d\u0438\u0439 \u0441\u043f\u043e\u0441\u0456\u0431 \u0437\u0430\u0432\u0435\u0440\u0448\u0438\u0442\u0438 2019 \u0440\u0456\u043a \u0456 \u0440\u043e\u0437\u043f\u043e\u0447\u0430\u0442\u0438 \u041d\u043e\u0432\u0438\u0439 \u0440\u0456\u043a \u0456\u0437 \u0441\u0438\u043b\u043e\u044e!<\/strong> \u041c\u0438 \u043d\u0435\u0432\u0442\u043e\u043c\u043d\u043e \u043f\u0440\u0430\u0446\u044e\u0432\u0430\u043b\u0438 \u043d\u0430\u0434 \u0442\u0438\u043c, \u0449\u043e\u0431 \u0441\u0443\u0442\u0442\u0454\u0432\u043e \u0432\u043f\u043b\u0438\u043d\u0443\u0442\u0438 \u043d\u0430 \u0436\u0438\u0442\u0442\u044f \u0434\u0456\u0442\u0435\u0439 \u0456 \u043c\u043e\u043b\u043e\u0434\u0438\u0445 \u043b\u044e\u0434\u0435\u0439, \u0445\u0432\u043e\u0440\u0438\u0445 \u043d\u0430 \u043f\u0440\u043e\u0433\u0435\u0440\u0456\u044e, \u0456 \u0446\u044f \u0437\u0430\u044f\u0432\u0430 \u043d\u0430\u0431\u043b\u0438\u0436\u0430\u0454 \u043d\u0430\u0441 \u0434\u043e \u0446\u0456\u0454\u0457 \u043c\u0435\u0442\u0438.<\/p>\n<p><strong>\u0414\u042f\u041a\u0423\u042e \u0412\u0410\u041c \u0412\u0421\u0406\u041c<\/strong>\u00a0\u0437\u0430 \u043f\u0456\u0434\u0442\u0440\u0438\u043c\u043a\u0443 \u0434\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u043d\u044f, \u044f\u043a\u0435 \u043d\u0435 \u0442\u0456\u043b\u044c\u043a\u0438 \u043f\u0440\u0438\u0432\u0435\u043b\u043e \u043d\u0430\u0441 \u0434\u043e \u0446\u044c\u043e\u0433\u043e \u043a\u043b\u044e\u0447\u043e\u0432\u043e\u0433\u043e \u043c\u043e\u043c\u0435\u043d\u0442\u0443, \u0430\u043b\u0435 \u0439 \u0434\u043e\u0437\u0432\u043e\u043b\u044f\u0454 \u043d\u0430\u043c \u043f\u0440\u043e\u0434\u043e\u0432\u0436\u0443\u0432\u0430\u0442\u0438 \u0440\u043e\u0431\u043e\u0442\u0443 \u043d\u0430\u0434 \u0432\u0456\u0434\u043a\u0440\u0438\u0442\u0442\u044f\u043c \u043d\u043e\u0432\u0438\u0445 \u043b\u0456\u043a\u0456\u0432, \u044f\u043a\u0456 \u0437\u0440\u0435\u0448\u0442\u043e\u044e \u0432\u0438\u043b\u0456\u043a\u0443\u044e\u0442\u044c \u0446\u0438\u0445 \u043d\u0430\u0434\u0437\u0432\u0438\u0447\u0430\u0439\u043d\u0438\u0445 \u0434\u0456\u0442\u0435\u0439.<\/p>\n<div id=\"attachment_9149\" style=\"width: 310px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-9149\" class=\"wp-image-9149 size-medium\" src=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/getting-drug-zoeycarly-April-2016-300x225.jpg\" alt=\"\" width=\"300\" height=\"225\" \/><p id=\"caption-attachment-9149\" class=\"wp-caption-text\">\u0417\u043e\u0457 \u0442\u0430 \u041a\u0430\u0440\u043b\u0456 \u043e\u0442\u0440\u0438\u043c\u0443\u044e\u0442\u044c \u043b\u0456\u043a\u0443\u0432\u0430\u043d\u043d\u044f \u043b\u043e\u043d\u0430\u0444\u0430\u0440\u043d\u0456\u0431\u043e\u043c \u043f\u0456\u0434 \u0447\u0430\u0441 \u043e\u0441\u0442\u0430\u043d\u043d\u044c\u043e\u0433\u043e \u0432\u0456\u0437\u0438\u0442\u0443 \u0434\u043e \u0411\u043e\u0441\u0442\u043e\u043d\u0430 \u0434\u043b\u044f \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u044c.<\/p><\/div>\n<p>&nbsp;<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"<p>\u041c\u0438 \u0440\u0430\u0434\u0456 \u043f\u043e\u0432\u0456\u0434\u043e\u043c\u0438\u0442\u0438 \u043f\u0440\u043e \u0432\u0456\u0445\u0443 \u0432 \u043d\u0430\u0448\u0456\u0439 \u043c\u0456\u0441\u0456\u0457 \u0437 \u043b\u0456\u043a\u0443\u0432\u0430\u043d\u043d\u044f \u0442\u0430 \u043b\u0456\u043a\u0443\u0432\u0430\u043d\u043d\u044f \u0434\u0456\u0442\u0435\u0439, \u0445\u0432\u043e\u0440\u0438\u0445 \u043d\u0430 \u043f\u0440\u043e\u0433\u0435\u0440\u0456\u044e: \u0443 \u043f\u0430\u0440\u0442\u043d\u0435\u0440\u0441\u0442\u0432\u0456 \u0437 The Progeria Research Foundation Eiger BioPharmaceuticals \u043f\u043e\u0434\u0430\u043b\u0430 \u0434\u043e FDA \u043f\u0435\u0440\u0448\u0443 \u0447\u0430\u0441\u0442\u0438\u043d\u0443 \u0441\u0432\u043e\u0454\u0457 \u0437\u0430\u044f\u0432\u043a\u0438 \u043d\u0430 \u0441\u0445\u0432\u0430\u043b\u0435\u043d\u043d\u044f \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0443 \u043b\u043e\u043d\u0430\u0444\u0430\u0440\u043d\u0456\u0431 \u0434\u043b\u044f \u043b\u0456\u043a\u0443\u0432\u0430\u043d\u043d\u044f \u041f\u0440\u043e\u0433\u0435\u0440\u0456\u044f. <\/p>","protected":false},"author":2,"featured_media":9151,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<p>We\u2019re thrilled to announce a milestone in our mission to treat and cure children with Progeria: In partnership with The Progeria Research Foundation, Eiger BioPharmaceuticals has submitted to the FDA the first part of its application seeking approval of the drug lonafarnib as a treatment for Progeria.<\/p><p>This first-ever submission is the culmination of twelve years of research data and four PRF-funded clinical trials in partnership with Brown University and Boston Children\u2019s Hospital, and made possible by the courageous children and their families, as well as YOU - PRF\u2019s wonderful community of donors.<\/p><p>You can read more about this exciting news <strong><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/PRF-Lonafarnib-NDA-Submission-Press-Release-FINAL-12-16-19.pdf\">here<\/a><\/strong>.<\/p><p>Eiger BioPharmaceuticals will submit completed portions of the application for FDA review on an ongoing basis, with plans to finish the submission in the first quarter of the new year. Approval will enable these children and young adults to access lonafarnib \u2013 which has been shown to give them stronger hearts and longer lives - by prescription, instead of through our clinical trials, in the US and possibly in other countries as well.<\/p><p><strong>What a positive way to end 2019, and start the New Year strong!<\/strong> We have worked tirelessly to make a meaningful impact on the lives of children and young adults with Progeria, and this submission brings us closer to that goal.<\/p><p><strong>THANK YOU ALL<\/strong>\u00a0for supporting the research that not only has brought us to this pivotal point, but also allows us to continue working to discover new drugs that will ultimately cure these extraordinary children.<\/p>[caption id=\"attachment_9149\" align=\"alignnone\" width=\"300\"]<img class=\"wp-image-9149 size-medium\" src=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/getting-drug-zoeycarly-April-2016-300x225.jpg\" alt=\"\" width=\"300\" height=\"225\" \/> Zoey and Carly getting their lonafarnib treatment during their latest clinical trial visit to Boston.[\/caption]<p>\u00a0<\/p>","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[2],"tags":[],"class_list":["post-9148","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Submission of application to FDA for lonafarnib approval has begun! - The Progeria Research Foundation<\/title>\n<meta name=\"description\" content=\"In partnership with The Progeria Research Foundation, Eiger BioPharmaceuticals has submitted to the FDA the first part of its application seeking approval of the drug lonafarnib as a treatment for Progeria.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.progeriaresearch.org\/uk\/2019\/12\/18\/breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun\/\" \/>\n<meta property=\"og:locale\" content=\"uk_UA\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Submission of application to FDA for lonafarnib approval has begun! - The Progeria Research Foundation\" \/>\n<meta property=\"og:description\" content=\"In partnership with The Progeria Research Foundation, Eiger BioPharmaceuticals has submitted to the FDA the first part of its application seeking approval of the drug lonafarnib as a treatment for Progeria.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.progeriaresearch.org\/uk\/2019\/12\/18\/breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun\/\" \/>\n<meta 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=\"2019-12-18T18:01:35+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-03-23T15:03:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/getting-drug-zoeycarly-April-2016-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2201\" \/>\n\t<meta property=\"og:image:height\" content=\"2403\" \/>\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. 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