{"id":21754,"date":"2026-10-21T15:04:35","date_gmt":"2026-10-21T15:04:35","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21754"},"modified":"2026-10-21T15:04:35","modified_gmt":"2026-10-21T15:04:35","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-vyvgart-efgartigimod-alfa-date-dautorisation-10-08-2022-revision-11-statut-autorise-t","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21754","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Vyvgart, efgartigimod alfa, Date d\u2019autorisation : 10\/08\/2022, R\u00e9vision : 11, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Vyvgart est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte dans deux maladies rares : la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e et la polyradiculon\u00e9vrite chronique inflammatoire d\u00e9my\u00e9linisante (CIDP). Pour la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e, il s\u2019adresse aux patients dont le syst\u00e8me immunitaire produit des anticorps dirig\u00e9s contre le r\u00e9cepteur de l\u2019ac\u00e9tylcholine situ\u00e9 sur les cellules musculaires, en association avec d\u2019autres traitements de la myasth\u00e9nie. Pour la CIDP, il est utilis\u00e9 chez des patients dont la maladie s\u2019aggrave ou r\u00e9cidive apr\u00e8s un traitement pr\u00e9alable par cortico\u00efdes ou immunoglobulines. Ces deux pathologies \u00e9tant rares, Vyvgart a obtenu le statut de m\u00e9dicament orphelin respectivement le 21 mars 2018 (myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e) et le 14 janvier 2022 (CIDP).<\/p>\n<p>Le m\u00e9dicament contient la substance active efgartigimod alfa. Il est soumis \u00e0 prescription m\u00e9dicale et le traitement doit \u00eatre initi\u00e9 par un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge des troubles neuromusculaires. Pour la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e, Vyvgart est administr\u00e9 soit en perfusion intraveineuse, soit par injection sous-cutan\u00e9e, une fois par semaine pendant un cycle de 4 semaines, le nombre de cycles \u00e9tant ajust\u00e9 en fonction de la r\u00e9ponse clinique. Pour la CIDP, il est administr\u00e9 par injection sous-cutan\u00e9e hebdomadaire, avec possibilit\u00e9 d\u2019espacer les injections \u00e0 une semaine sur deux selon la r\u00e9ponse au traitement. Apr\u00e8s 4 injections dans la CIDP et 5 injections dans la myasth\u00e9nie grave, le patient ou un aidant peut r\u00e9aliser lui-m\u00eame les injections sous-cutan\u00e9es, sous r\u00e9serve d\u2019une formation adapt\u00e9e, ce qui peut avoir des implications organisationnelles pour les soins ambulatoires et l\u2019accompagnement des proches aidants.<\/p>\n<p>Sur le plan m\u00e9canistique, dans la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e, des auto-anticorps endommagent les r\u00e9cepteurs de l\u2019ac\u00e9tylcholine, entra\u00eenant une faiblesse musculaire. Dans la CIDP, les auto-anticorps d\u00e9truisent la gaine de protection des nerfs, provoquant une faiblesse musculaire et des troubles sensitifs. Efgartigimod alfa se lie au r\u00e9cepteur Fc n\u00e9onatal (FcRn), impliqu\u00e9 dans la r\u00e9gulation des taux d\u2019anticorps circulants. En bloquant ce r\u00e9cepteur, Vyvgart r\u00e9duit les taux d\u2019auto-anticorps, prot\u00e9geant ainsi les r\u00e9cepteurs de l\u2019ac\u00e9tylcholine et les gaines nerveuses et contribuant \u00e0 la r\u00e9duction des sympt\u00f4mes des deux maladies. L\u2019information disponible souligne la n\u00e9cessit\u00e9 d\u2019une utilisation encadr\u00e9e par des sp\u00e9cialistes et renvoie pour les modalit\u00e9s compl\u00e8tes d\u2019emploi au r\u00e9sum\u00e9 des caract\u00e9ristiques du produit et \u00e0 la notice. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/vyvgart\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Vyvgart est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte dans deux maladies rares : la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e et la polyradiculon\u00e9vrite chronique inflammatoire d\u00e9my\u00e9linisante (CIDP). Pour la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e, il s\u2019adresse [&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-21754","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\/21754","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=21754"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21754\/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=21754"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21754"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}