{"id":29923,"date":"2020-08-19T09:00:00","date_gmt":"2020-08-19T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/actualizacion-sobre-la-aprobacion-de-la-fda-para-la-terapia-genica-con-valoctocogene-roxaparvovec-para-la-hemofilia-a-grave\/"},"modified":"2024-04-21T12:43:15","modified_gmt":"2024-04-21T16:43:15","slug":"actualizacion-sobre-la-aprobacion-de-la-fda-para-la-terapia-genica-con-valoctocogene-roxaparvovec-para-la-hemofilia-a-grave","status":"publish","type":"post","link":"https:\/\/wfh.org\/es\/article\/actualizacion-sobre-la-aprobacion-de-la-fda-para-la-terapia-genica-con-valoctocogene-roxaparvovec-para-la-hemofilia-a-grave\/","title":{"rendered":"Actualizaci\u00f3n sobre la aprobaci\u00f3n de la FDA para la terapia g\u00e9nica con valoctocogene roxaparvovec para la hemofilia A grave"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"29923\" class=\"elementor elementor-29923 elementor-17940\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-17d5fd6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"17d5fd6\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fcb5976\" data-id=\"fcb5976\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e5d8f81 elementor-widget elementor-widget-text-editor\" data-id=\"e5d8f81\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p class=\"\">En relaci\u00f3n con dicha declaraci\u00f3n, el doctor Glenn Pierce, PhD, vicepresidente m\u00e9dico de la FMH, afirm\u00f3 que \u201cla terapia g\u00e9nica para la cura de la hemofilia \u2012el sue\u00f1o de muchas personas\u2012 contin\u00faa siendo una tecnolog\u00eda de desarrollo incipiente. Las respuestas individuales de los pacientes son variables, err\u00e1ticas, impredecibles y, en algunos casos, no duraderas a largo plazo. Todav\u00eda tenemos mucho que aprender a fin de poder aprovechar esta tecnolog\u00eda en beneficio de las personas con hemofilia alrededor del mundo. Conf\u00edo en que esto ocurrir\u00e1, pero tomar\u00e1 tiempo responder algunas preguntas dif\u00edciles.\u201d<\/p>\r\n\r\n<p class=\"\">Lea la declaraci\u00f3n de BioMarin aqu\u00ed:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9a7a130 elementor-widget elementor-widget-text-editor\" data-id=\"9a7a130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\"><strong>BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A<\/strong><\/p><p class=\"\">FDA Introduces New Recommendation for 2-Year Annualized Bleeding Rate (ABR) as Primary Endpoint for Ongoing Phase 3 Study 270-301<\/p><p class=\"\">BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company\u2019s Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on August 18, 2020. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.<\/p><p class=\"\">Having previously agreed with the Agency on the extent of data necessary to support the BLA, the FDA introduced a new recommendation for two years of data from the Company\u2019s ongoing 270-301 study (Phase 3) to provide substantial evidence of a durable effect using Annualized Bleeding Rate (ABR) as the primary endpoint. The Agency first informed the Company of this recommendation in the CRL having not raised this at any time during development or review. The Agency recommended that the Company complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants. FDA concluded that the differences between Study 270-201 (Phase 1\/2) and the Phase 3 study limited its ability to rely on the Phase 1\/2 study to support durability of effect. The Phase 3 study was fully enrolled in November 2019, and the last patient will complete two years of follow up in November 2021.<\/p><p class=\"\">The Company plans to meet with the Agency in the coming weeks to align on the next steps to obtain approval.<\/p><p class=\"\">\u201cWe remain committed to the hemophilia community and to leading the way to the first ever gene therapy in hemophilia A,\u201d said Jean-Jacques Bienaim\u00e9, Chairman and Chief Executive Officer of BioMarin. \u201cWe are surprised and disappointed that the FDA introduced new expectations for the first time in the Complete Response Letter. We are confident in valoctocogene roxaparvovec gene therapy and its potential to redefine the treatment paradigm for people with hemophilia A.\u201d<\/p><p class=\"\">The application was based on the Phase 3 study interim analysis of study participants treated with investigational product manufactured by the to-be-commercialized process and three-year data from the Phase 1\/2 Study. The FDA had granted valoctocogene roxaparvovec Priority Review status and Breakthrough Therapy and Orphan Drug designations. Valoctocogene roxaparvovec maintains Breakthrough Therapy and Orphan Drug designations.<\/p><p class=\"\">The ongoing valoctocogene roxaparvovec clinical trials will continue while BioMarin is exploring next steps to obtain approval. The European Medicines Agency (EMA) review of the Company\u2019s Marketing Authorization Application (MAA) for valoctocogene roxaparvovec is ongoing.<\/p><p class=\"\">To view this release online and get more information about BioMarin : IR Room visit: <a href=\"https:\/\/investors.biomarin.com\/2020-08-19-BioMarin-Receives-Complete-Response-Letter-CRL-from-FDA-for-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Severe-Hemophilia-A\" target=\"_blank\" rel=\"noopener\">https:\/\/investors.biomarin.com\/2020-08-19-BioMarin-Receives-Complete-Response-Letter-CRL-from-FDA-for-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Severe-Hemophilia-A<\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>La empresa farmac\u00e9utica BioMarin emiti\u00f3 una declaraci\u00f3n relacionada con el estado del proceso de aprobaci\u00f3n de la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA por su sigla en ingl\u00e9s) para la terapia g\u00e9nica con valoctocogene roxaparvovec para la hemofilia A grave.<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[121,196],"tags":[],"search-category":[],"class_list":["post-29923","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declaraciones-y-notificaciones-de-la-fmh","category-noticias-medicas"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Actualizaci\u00f3n sobre la aprobaci\u00f3n de la FDA para la terapia g\u00e9nica con valoctocogene roxaparvovec para la hemofilia A grave | FMH - Federaci\u00f3n Mundial de Hemofilia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/es\/article\/actualizacion-sobre-la-aprobacion-de-la-fda-para-la-terapia-genica-con-valoctocogene-roxaparvovec-para-la-hemofilia-a-grave\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Actualizaci\u00f3n sobre la aprobaci\u00f3n de la FDA para la terapia g\u00e9nica con valoctocogene roxaparvovec para la hemofilia A grave\" \/>\n<meta property=\"og:description\" content=\"La empresa farmac\u00e9utica BioMarin emiti\u00f3 una declaraci\u00f3n relacionada con el estado del proceso de aprobaci\u00f3n de la Administraci\u00f3n de Alimentos y Medicamentos de EE. 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