{"id":21438,"date":"2026-10-19T11:46:56","date_gmt":"2026-10-19T11:46:56","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21438"},"modified":"2026-10-19T11:46:56","modified_gmt":"2026-10-19T11:46:56","slug":"rapport-europeen-public-devaluation-des-medicaments-a-usage-humain-epar-pavblu-aflibercept-revision-3-statut-autorise-titre-traduit-en-francais-par-lia","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21438","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation des m\u00e9dicaments \u00e0 usage humain (EPAR) : Pavblu, aflibercept, R\u00e9vision : 3, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Pavblu est un m\u00e9dicament biologique destin\u00e9 au traitement de plusieurs atteintes oculaires chez l\u2019adulte. Il est indiqu\u00e9 dans la d\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l\u2019\u00e2ge (DMLA) de forme humide, caract\u00e9ris\u00e9e par une n\u00e9ovascularisation choro\u00efdienne anormale sous la macula entra\u00eenant fuites et \u0153d\u00e8me. Il est \u00e9galement indiqu\u00e9 en cas de baisse de vision li\u00e9e \u00e0 un \u0153d\u00e8me maculaire cons\u00e9cutif \u00e0 une occlusion veineuse r\u00e9tinienne centrale (CRVO) ou de branche (BRVO), \u00e0 un \u0153d\u00e8me maculaire d\u2019origine diab\u00e9tique, ainsi qu\u2019en cas de baisse de vision due \u00e0 une n\u00e9ovascularisation choro\u00efdienne chez les patients myopes.<\/p>\n<p>Pavblu contient de l\u2019aflibercept et est un m\u00e9dicament biosimilaire d\u2019Eylea, m\u00e9dicament de r\u00e9f\u00e9rence d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne. Des \u00e9tudes de laboratoire ont montr\u00e9 que la substance active de Pavblu est hautement similaire \u00e0 celle d\u2019Eylea en termes de structure, de puret\u00e9 et d\u2019activit\u00e9 biologique, et que l\u2019administration de Pavblu induit des concentrations syst\u00e9miques comparables \u00e0 celles observ\u00e9es avec Eylea.<\/p>\n<p>Le m\u00e9canisme d\u2019action repose sur un blocage du facteur de croissance endoth\u00e9lial vasculaire A (VEGF-A) et d\u2019autres prot\u00e9ines comme le facteur de croissance placentaire (PlGF), impliqu\u00e9s dans la stimulation de la croissance vasculaire anormale et des ph\u00e9nom\u00e8nes de fuite et de gonflement au niveau de la r\u00e9tine et de la choro\u00efde. En neutralisant ces facteurs, l\u2019aflibercept limite la croissance de vaisseaux anormaux et contr\u00f4le l\u2019\u0153d\u00e8me.<\/p>\n<p>Une \u00e9tude clinique men\u00e9e chez 579 adultes atteints de DMLA humide a montr\u00e9 une efficacit\u00e9 \u00e9quivalente entre Pavblu et Eylea : apr\u00e8s 8 semaines de traitement, l\u2019acuit\u00e9 visuelle mesur\u00e9e en nombre de lettres reconnues sur une \u00e9chelle standard augmentait en moyenne d\u2019environ 6,5 lettres dans les deux groupes. En tant que biosimilaire, Pavblu b\u00e9n\u00e9ficie des donn\u00e9es d\u2019efficacit\u00e9 d\u00e9j\u00e0 produites avec Eylea, ce qui limite le besoin de r\u00e9p\u00e9ter l\u2019ensemble des \u00e9tudes cliniques.<\/p>\n<p>Pavblu est disponible dans l\u2019UE sous forme de solution injectable pour administration intravitr\u00e9enne (dans le corps vitr\u00e9 de l\u2019\u0153il). Il est soumis \u00e0 prescription m\u00e9dicale et doit \u00eatre administr\u00e9 par un m\u00e9decin qualifi\u00e9, exp\u00e9riment\u00e9 dans ce type d\u2019injection. Le sch\u00e9ma d\u2019administration pr\u00e9voit des injections r\u00e9p\u00e9t\u00e9es \u00e0 intervalles d\u2019au moins un mois, la fr\u00e9quence \u00e9tant adapt\u00e9e \u00e0 la pathologie trait\u00e9e et \u00e0 la r\u00e9ponse du patient. Les informations pratiques d\u2019utilisation rel\u00e8vent de la notice du m\u00e9dicament et de la prise en charge par les professionnels de sant\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/pavblu\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Pavblu est un m\u00e9dicament biologique destin\u00e9 au traitement de plusieurs atteintes oculaires chez l\u2019adulte. Il est indiqu\u00e9 dans la d\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l\u2019\u00e2ge (DMLA) de forme humide, caract\u00e9ris\u00e9e par [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21438","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21438","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21438"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21438\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21438"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21438"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21438"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}