Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour le m\u00e9dicament Fovlussea. Ce m\u00e9dicament, d\u00e9velopp\u00e9 par Accord Healthcare S.L.U., est destin\u00e9 au traitement chez l\u2019adulte de plusieurs pathologies oculaires : la d\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l\u2019\u00e2ge de forme n\u00e9ovasculaire (DMLA humide), la d\u00e9ficience visuelle li\u00e9e \u00e0 l\u2019\u0153d\u00e8me maculaire diab\u00e9tique, la r\u00e9tinopathie diab\u00e9tique prolif\u00e9rante, la d\u00e9ficience visuelle due \u00e0 un \u0153d\u00e8me maculaire secondaire \u00e0 une occlusion veineuse r\u00e9tinienne (branche ou centrale) et la d\u00e9ficience visuelle due \u00e0 une n\u00e9ovascularisation choro\u00efdienne.<\/p>\n
Fovlussea sera disponible sous forme de solution injectable \u00e0 10 mg\/ml et contient comme substance active le ranibizumab, class\u00e9 comme agent antin\u00e9ovascularisation (code ATC S01LA04). Il s\u2019agit d\u2019un fragment d\u2019anticorps monoclonal qui module l\u2019angiogen\u00e8se en inhibant le facteur de croissance de l\u2019endoth\u00e9lium vasculaire A (VEGF-A). Fovlussea est un m\u00e9dicament biosimilaire du m\u00e9dicament de r\u00e9f\u00e9rence Lucentis (ranibizumab), autoris\u00e9 dans l\u2019Union europ\u00e9enne depuis le 22 janvier 2007. Les donn\u00e9es examin\u00e9es par le CHMP indiquent une qualit\u00e9, une s\u00e9curit\u00e9 et une efficacit\u00e9 comparables \u00e0 celles de Lucentis.<\/p>\n
L\u2019administration de Fovlussea doit \u00eatre r\u00e9alis\u00e9e par un ophtalmologiste qualifi\u00e9 et exp\u00e9riment\u00e9 dans les injections intravitr\u00e9ennes. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation figureront dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit, qui sera publi\u00e9 par l\u2019EMA dans toutes les langues officielles de l\u2019Union europ\u00e9enne apr\u00e8s la d\u00e9cision formelle d\u2019autorisation de mise sur le march\u00e9 par la Commission europ\u00e9enne. Cette d\u00e9cision s\u2019inscrit dans le cadre plus large des travaux du CHMP, dont les principales conclusions pour la session des 12\u201115 octobre 2026 ont \u00e9t\u00e9 rendues publiques le 16 octobre 2026. Sur le plan des politiques de sant\u00e9, ce d\u00e9veloppement illustre la poursuite de l\u2019int\u00e9gration de m\u00e9dicaments biosimilaires en ophtalmologie au niveau europ\u00e9en, avec des enjeux potentiels en mati\u00e8re d\u2019acc\u00e8s aux traitements et de ma\u00eetrise des d\u00e9penses, dans un contexte de forte pr\u00e9valence des pathologies oculaires li\u00e9es \u00e0 l\u2019\u00e2ge et au diab\u00e8te. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur […]<\/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-21274","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\/21274","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=21274"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21274\/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=21274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}