Dimethyl fumarate Accord est un m\u00e9dicament destin\u00e9 au traitement de la scl\u00e9rose en plaques (SEP) de forme r\u00e9mittente-r\u00e9currente chez l\u2019adulte et l\u2019adolescent \u00e0 partir de 13 ans. Il s\u2019agit d\u2019un g\u00e9n\u00e9rique contenant la m\u00eame substance active (dim\u00e9thylfumarate) que le m\u00e9dicament de r\u00e9f\u00e9rence Tecfidera, d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne. L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) indique que les \u00e9tudes cliniques de b\u00e9n\u00e9fices\/risques d\u00e9j\u00e0 r\u00e9alis\u00e9es avec Tecfidera n\u2019ont pas \u00e9t\u00e9 r\u00e9p\u00e9t\u00e9es pour Dimethyl fumarate Accord, conform\u00e9ment au cadre applicable aux g\u00e9n\u00e9riques.<\/p>\n
Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et l\u2019instauration du traitement doit se faire sous la supervision d\u2019un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge de la SEP. Il est disponible sous forme de g\u00e9lules administr\u00e9es par voie orale, deux fois par jour au cours des repas. Une dose initiale plus faible est prescrite la premi\u00e8re semaine, puis augment\u00e9e \u00e0 partir de la deuxi\u00e8me semaine. En cas d\u2019effets ind\u00e9sirables tels que bouff\u00e9es vasomotrices (flush) ou troubles gastro-intestinaux, une r\u00e9duction temporaire de la dose est possible.<\/p>\n
Sur le plan pharmacologique, le dim\u00e9thylfumarate est pr\u00e9sent\u00e9 comme agissant via l\u2019activation de la prot\u00e9ine Nrf2, qui r\u00e9gule des g\u00e8nes impliqu\u00e9s dans la production d\u2019antioxydants contribuant \u00e0 la protection cellulaire. Il a montr\u00e9 des effets de r\u00e9duction de l\u2019inflammation et de modulation de l\u2019activit\u00e9 du syst\u00e8me immunitaire dans la SEP. L\u2019entreprise a fourni \u00e0 l\u2019EMA des donn\u00e9es de qualit\u00e9 pharmaceutique ainsi que des \u00e9tudes d\u00e9montrant la bio\u00e9quivalence avec Tecfidera, c\u2019est\u2011\u00e0\u2011dire l\u2019obtention de concentrations similaires de substance active dans l\u2019organisme et une efficacit\u00e9 attendue \u00e9quivalente.<\/p>\n
Sur cette base, l\u2019EMA conclut que Dimethyl fumarate Accord pr\u00e9sente une qualit\u00e9 comparable et une bio\u00e9quivalence av\u00e9r\u00e9e avec Tecfidera, et que, comme pour le m\u00e9dicament de r\u00e9f\u00e9rence, le rapport b\u00e9n\u00e9fices\/risques est favorable pour l\u2019indication autoris\u00e9e. Le m\u00e9dicament peut donc \u00eatre autoris\u00e9 dans l\u2019Union europ\u00e9enne en tant que g\u00e9n\u00e9rique de Tecfidera. Cette d\u00e9cision concerne principalement la r\u00e9gulation pharmaceutique au niveau europ\u00e9en et peut avoir des implications potentielles en mati\u00e8re d\u2019acc\u00e8s au traitement et de ma\u00eetrise des d\u00e9penses de sant\u00e9, dans le cadre des politiques relatives \u00e0 la prise en charge de la scl\u00e9rose en plaques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Dimethyl fumarate Accord est un m\u00e9dicament destin\u00e9 au traitement de la scl\u00e9rose en plaques (SEP) de forme r\u00e9mittente-r\u00e9currente chez l\u2019adulte et l\u2019adolescent \u00e0 partir de 13 ans. Il s\u2019agit d\u2019un […]<\/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-18495","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\/18495","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=18495"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18495\/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=18495"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18495"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18495"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}