{"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\/pt\/2019\/12\/18\/breaking-news-submission-of-application-to-fda-for-lonafarnib-approval-has-begun\/","title":{"rendered":"O envio do pedido de aprova\u00e7\u00e3o do lonafarnib ao FDA j\u00e1 come\u00e7ou!"},"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>Este primeiro envio \u00e9 o resultado de doze anos de dados de pesquisa e quatro ensaios cl\u00ednicos financiados pela PRF em parceria com a Brown University e o Boston Children&#039;s Hospital, e foi poss\u00edvel gra\u00e7as \u00e0s crian\u00e7as corajosas e suas fam\u00edlias, assim como a VOC\u00ca, a maravilhosa comunidade de doadores da PRF.<\/p>\n<p>Voc\u00ea pode ler mais sobre esta not\u00edcia emocionante <strong><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2019\/12\/PRF-Lonafarnib-NDA-Submission-Press-Release-FINAL-12-16-19.pdf\">aqui<\/a><\/strong>.<\/p>\n<p>A Eiger BioPharmaceuticals enviar\u00e1 partes conclu\u00eddas do requerimento para revis\u00e3o da FDA de forma cont\u00ednua, com planos de finalizar o envio no primeiro trimestre do ano novo. A aprova\u00e7\u00e3o permitir\u00e1 que essas crian\u00e7as e jovens adultos acessem o lonafarnib \u2013 que demonstrou dar a eles cora\u00e7\u00f5es mais fortes e vidas mais longas \u2013 por prescri\u00e7\u00e3o, em vez de por meio de nossos ensaios cl\u00ednicos, nos EUA e possivelmente em outros pa\u00edses tamb\u00e9m.<\/p>\n<p><strong>Que maneira positiva de terminar 2019 e come\u00e7ar o Ano Novo com for\u00e7a!<\/strong> Trabalhamos incansavelmente para causar um impacto significativo na vida de crian\u00e7as e jovens adultos com Prog\u00e9ria, e esta submiss\u00e3o nos aproxima desse objetivo.<\/p>\n<p><strong>OBRIGADO A TODOS<\/strong>\u00a0por apoiar a pesquisa que n\u00e3o apenas nos trouxe a esse ponto crucial, mas tamb\u00e9m nos permite continuar trabalhando para descobrir novos medicamentos que acabar\u00e3o curando essas crian\u00e7as extraordin\u00e1rias.<\/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 e Carly recebendo tratamento com lonafarnib durante sua \u00faltima visita de teste cl\u00ednico em 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>Estamos felizes em anunciar um marco em nossa miss\u00e3o de tratar e curar crian\u00e7as com Prog\u00e9ria: em parceria com a Progeria Research Foundation, a Eiger BioPharmaceuticals enviou ao FDA a primeira parte de seu pedido de aprova\u00e7\u00e3o do medicamento lonafarnib como tratamento para 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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