{"id":28990,"date":"2020-08-19T09:00:00","date_gmt":"2020-08-19T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/"},"modified":"2024-04-22T14:30:52","modified_gmt":"2024-04-22T18:30:52","slug":"mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/","title":{"rendered":"Mise \u00e0 jour concernant l\u2019autorisation de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"28990\" class=\"elementor elementor-28990 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\" data-e-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\" data-e-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-e-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\t\t<p class=\"\">\u00c0 ce sujet, le docteur Glenn Pierce, vice-pr\u00e9sident de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie en charge des affaires m\u00e9dicales, a d\u00e9clar\u00e9 : \u00ab la th\u00e9rapie g\u00e9nique pour gu\u00e9rir l\u2019h\u00e9mophilie, dont beaucoup r\u00eavent, reste une technologie qui n\u2019en est qu\u2019aux premi\u00e8res \u00e9tapes de son d\u00e9veloppement. Les r\u00e9ponses individuelles des patients sont variables, ne sont pas fiables ni pr\u00e9visibles et dans certains cas, ne sont pas durables sur le long terme. Il nous reste encore beaucoup \u00e0 apprendre afin d\u2019exploiter cette technologie et d\u2019en faire b\u00e9n\u00e9ficier les personnes atteintes d\u2019h\u00e9mophilie. J\u2019y crois fermement, mais il faudra du temps pour r\u00e9pondre \u00e0 certaines questions complexes \u00bb.<\/p>\r\n\r\n<p class=\"\">Nous reprenons ici la d\u00e9claration de BioMarin\u00a0:<\/p>\t\t\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-e-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\t\t<p class=\"\"><strong>BioMarin re\u00e7oit une lettre de r\u00e9ponse compl\u00e8te de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie\u00a0A s\u00e9v\u00e8re<\/strong><\/p>\r\n\r\n<p class=\"\">La FDA introduit une nouvelle recommandation pour le taux annualis\u00e9 de saignement (TAS) \u00e0 deux ans comme crit\u00e8re d\u2019\u00e9valuation principal dans l\u2019\u00e9tude de phase\u00a0III en cours 270-301<\/p>\r\n\r\n<p class=\"\">BioMarin Pharmaceutical\u00a0Inc. (NASDAQ\u00a0: BMRN) annonce ce jour que la\u00a0<em>Food and Drug Administration\u00a0<\/em>a publi\u00e9 une lettre de r\u00e9ponse compl\u00e8te (<em>Complete Response Letter<\/em>, CRL) \u00e0 sa demande de licence de produit biologique (<em>Biologics License Application<\/em>, BLA) du 18\u00a0ao\u00fbt 2020 pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie\u00a0A s\u00e9v\u00e8re. La FDA publie une CRL pour indiquer que le cycle d\u2019examen d\u2019une demande est termin\u00e9 et que la demande n\u2019est pas pr\u00eate pour autorisation dans sa forme actuelle.<\/p>\r\n\r\n<p class=\"\">L\u2019\u00e9tendue des donn\u00e9es n\u00e9cessaires pour \u00e9tayer la BLA avait \u00e9t\u00e9 convenue avec la FDA, mais celle-ci a introduit une nouvelle recommandation pour les deux ann\u00e9es de donn\u00e9es de l\u2019\u00e9tude 270-301 en cours (phase\u00a0III) afin de fournir des preuves substantielles d\u2019un effet durable \u00e0 l\u2019aide du taux annualis\u00e9 de saignement (TAS) comme crit\u00e8re d\u2019\u00e9valuation principal. La FDA a pour la premi\u00e8re fois inform\u00e9 la soci\u00e9t\u00e9 de cette recommandation dans la CRL, n\u2019ayant soulev\u00e9 ce point \u00e0 aucun moment durant le d\u00e9veloppement ou l\u2019examen. Elle a recommand\u00e9 que la soci\u00e9t\u00e9 termine l\u2019\u00e9tude de phase\u00a0III et soumette les donn\u00e9es d\u2019innocuit\u00e9 et d\u2019efficacit\u00e9 du suivi \u00e0 deux ans pour tous les participants de l\u2019\u00e9tude. La FDA a conclu que les diff\u00e9rences entre l\u2019\u00e9tude 270-201 (phase\u00a0I\/II) et l\u2019\u00e9tude de phase\u00a0III limitaient sa capacit\u00e9 \u00e0 s\u2019appuyer sur l\u2019\u00e9tude de phase\u00a0I\/II pour \u00e9tayer la durabilit\u00e9 de l\u2019effet. Le recrutement de l\u2019\u00e9tude de phase\u00a0III s\u2019est termin\u00e9 en novembre\u00a02019 et le dernier patient parviendra \u00e0 la fin des deux ann\u00e9es de suivi en novembre\u00a02021.<\/p>\r\n\r\n<p class=\"\">BioMarin pr\u00e9voit de rencontrer la FDA dans les semaines \u00e0 venir afin de se mettre d\u2019accord sur les \u00e9tapes suivantes pour l\u2019obtention de l\u2019autorisation.<\/p>\r\n\r\n<p class=\"\">\u00ab\u00a0Notre engagement envers la communaut\u00e9 des personnes atteintes d\u2019h\u00e9mophilie reste intact, de m\u00eame que notre volont\u00e9 d\u2019ouvrir la voie vers la toute premi\u00e8re th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie\u00a0A,\u00a0\u00bb a indiqu\u00e9 Jean-Jacques Bienaim\u00e9, pr\u00e9sident et directeur g\u00e9n\u00e9ral de BioMarin. \u00ab\u00a0Nous sommes \u00e0 la fois surpris et d\u00e9\u00e7us que la FDA ait introduit de nouvelles attentes au stade de la lettre de r\u00e9ponse compl\u00e8te. Nous sommes convaincus de la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec et de son potentiel de red\u00e9finition du paradigme th\u00e9rapeutique pour les personnes atteintes d\u2019h\u00e9mophilie\u00a0A.\u00a0\u00bb<\/p>\r\n\r\n<p class=\"\">La demande reposait sur l\u2019analyse interm\u00e9diaire de l\u2019\u00e9tude de phase\u00a0III des participants \u00e0 l\u2019\u00e9tude trait\u00e9s par le produit exp\u00e9rimental fabriqu\u00e9 selon le processus destin\u00e9 \u00e0 \u00eatre commercialis\u00e9, ainsi que sur les donn\u00e9es \u00e0 trois ans de l\u2019\u00e9tude de phase\u00a0I\/II. La FDA a accord\u00e9 au valoctocog\u00e8ne roxaparvovec le statut d\u2019examen prioritaire (<em>Priority Review<\/em>) et les d\u00e9signations de traitement novateur (<em>Breakthrough Therapy<\/em>) et de m\u00e9dicament orphelin (<em>Orphan Drug<\/em>). Le valoctocog\u00e8ne roxaparvovec conserve ces deux d\u00e9signations.<\/p>\r\n\r\n<p class=\"\">Les essais cliniques en cours portant sur le valoctocog\u00e8ne roxaparvovec se poursuivront alors que BioMarin explore les \u00e9tapes \u00e0 suivre pour l\u2019obtention de l\u2019autorisation. L\u2019examen par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) de la demande d\u2019autorisation de mise sur le march\u00e9 du valoctocog\u00e8ne roxaparvovec est en cours.<\/p>\r\n\r\n<p class=\"\">Pour consulter ce communiqu\u00e9 en ligne et obtenir de plus amples informations sur BioMarin, rendez-vous sur la salle de presse des relations investisseurs\u00a0: <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\">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\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>BioMarin a publi\u00e9 une d\u00e9claration concernant le statut du processus d\u2019autorisation de la <em>Food and Drug Administration<\/em> (FDA) aux \u00c9tats-Unis pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re. <\/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":[177,197],"tags":[],"search-category":[],"class_list":["post-28990","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","category-declarations-publiques-et-recommandations-de-la-fmh"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mise \u00e0 jour concernant l\u2019autorisation de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/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\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mise \u00e0 jour concernant l\u2019autorisation de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re\" \/>\n<meta property=\"og:description\" content=\"BioMarin a publi\u00e9 une d\u00e9claration concernant le statut du processus d\u2019autorisation de la Food and Drug Administration (FDA) aux \u00c9tats-Unis pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-08-19T13:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-22T18:30:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/Placeholder-Result-V1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Electra Rozakis\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Electra Rozakis\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\"},\"author\":{\"name\":\"Electra Rozakis\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/622f4b0ed56b8e4a987dd20bef774887\"},\"headline\":\"Mise \u00e0 jour concernant l\u2019autorisation de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re\",\"datePublished\":\"2020-08-19T13:00:00+00:00\",\"dateModified\":\"2024-04-22T18:30:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\"},\"wordCount\":814,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/Placeholder-Result-V1.png\",\"articleSection\":[\"Actualit\u00e9 m\u00e9dicale\",\"D\u00e9clarations publiques et recommandations de la FMH\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\",\"url\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-concernant-lautorisation-de-la-fda-pour-la-therapie-genique-par-valoctocogene-roxaparvovec-dans-lhemophilie-a-severe\/\",\"name\":\"Mise \u00e0 jour concernant l\u2019autorisation de la FDA pour la th\u00e9rapie g\u00e9nique par valoctocog\u00e8ne roxaparvovec dans l\u2019h\u00e9mophilie A s\u00e9v\u00e8re | FMH - 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