{"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\/fr\/2019\/12\/18\/breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun\/","title":{"rendered":"La soumission de la demande d\u2019approbation du lonafarnib \u00e0 la FDA a commenc\u00e9 !"},"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>Cette toute premi\u00e8re soumission est l&#039;aboutissement de douze ann\u00e9es de donn\u00e9es de recherche et de quatre essais cliniques financ\u00e9s par le PRF en partenariat avec l&#039;Universit\u00e9 Brown et le Boston Children&#039;s Hospital, et rendu possible par les enfants courageux et leurs familles, ainsi que par VOUS - la merveilleuse communaut\u00e9 de donateurs du PRF.<\/p>\n<p>Vous pouvez en savoir plus sur cette nouvelle passionnante <strong><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/PRF-Lonafarnib-NDA-Submission-Press-Release-FINAL-12-16-19.pdf\">ici<\/a><\/strong>.<\/p>\n<p>Eiger BioPharmaceuticals soumettra r\u00e9guli\u00e8rement les parties compl\u00e8tes de la demande \u00e0 l&#039;examen de la FDA, avec l&#039;intention de terminer la soumission au premier trimestre de la nouvelle ann\u00e9e. L&#039;approbation permettra \u00e0 ces enfants et jeunes adultes d&#039;acc\u00e9der au lonafarnib - qui s&#039;est av\u00e9r\u00e9 leur donner un c\u0153ur plus fort et une vie plus longue - sur ordonnance, au lieu de passer par nos essais cliniques, aux \u00c9tats-Unis et peut-\u00eatre dans d&#039;autres pays \u00e9galement.<\/p>\n<p><strong>Quelle fa\u00e7on positive de terminer 2019 et de commencer la nouvelle ann\u00e9e en force !<\/strong> Nous avons travaill\u00e9 sans rel\u00e2che pour avoir un impact significatif sur la vie des enfants et des jeunes adultes atteints de prog\u00e9ria, et cette soumission nous rapproche de cet objectif.<\/p>\n<p><strong>MERCI A TOUS<\/strong>\u00a0pour soutenir la recherche qui nous a non seulement amen\u00e9s \u00e0 ce point crucial, mais nous permet \u00e9galement de continuer \u00e0 travailler pour d\u00e9couvrir de nouveaux m\u00e9dicaments qui gu\u00e9riront finalement ces enfants extraordinaires.<\/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\">Zoey et Carly re\u00e7oivent leur traitement au lonafarnib lors de leur derni\u00e8re visite d&#039;essai clinique \u00e0 Boston.<\/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>Nous sommes ravis d&#039;annoncer une \u00e9tape importante dans notre mission de traitement et de gu\u00e9rison des enfants atteints de prog\u00e9ria : en partenariat avec la Progeria Research Foundation, Eiger BioPharmaceuticals a soumis \u00e0 la FDA la premi\u00e8re partie de sa demande d&#039;approbation du m\u00e9dicament lonafarnib comme traitement de la prog\u00e9ria. <\/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, 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