Le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a recommand\u00e9, lors de sa r\u00e9union d\u2019octobre 2026, l\u2019approbation de six nouveaux m\u00e9dicaments et l\u2019extension d\u2019indication de cinq m\u00e9dicaments d\u00e9j\u00e0 autoris\u00e9s dans l\u2019Union europ\u00e9enne.<\/p>\n
Le CHMP a \u00e9mis un avis favorable pour Rasonque (daraxonrasib) dans le traitement des adultes atteints d\u2019ad\u00e9nocarcinome pancr\u00e9atique m\u00e9tastatique ayant re\u00e7u au moins une ligne de traitement pr\u00e9alable. Ce m\u00e9dicament avait \u00e9t\u00e9 identifi\u00e9 comme prioritaire dans le cadre du projet \u00ab Cancer Medicines Pathfinder \u00bb de l\u2019EMA, en raison de son potentiel \u00e0 r\u00e9pondre \u00e0 un besoin m\u00e9dical non couvert en canc\u00e9rologie.<\/p>\n
Le comit\u00e9 a recommand\u00e9 l\u2019autorisation de mise sur le march\u00e9 de Foundayo (orforglipron), agoniste oral des r\u00e9cepteurs GLP\u20111 indiqu\u00e9 dans la prise en charge du poids et le traitement du diab\u00e8te de type 2 chez l\u2019adulte. Administr\u00e9 une fois par jour sous forme de comprim\u00e9, il constitue une alternative aux agonistes GLP\u20111 injectables ou oraux d\u00e9j\u00e0 disponibles.<\/p>\n
Yuviwel (navepegritide) a \u00e9galement re\u00e7u une recommandation d\u2019autorisation pour le traitement de l\u2019achondroplasie chez l\u2019enfant, une maladie g\u00e9n\u00e9tique rare li\u00e9e \u00e0 une mutation du g\u00e8ne FGFR3 affectant la croissance osseuse et entra\u00eenant une petite taille marqu\u00e9e.<\/p>\n
Deux m\u00e9dicaments biosimilaires ont obtenu un avis positif : Fovlussea (ranibizumab), indiqu\u00e9 dans plusieurs atteintes oculaires dont la d\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l\u2019\u00e2ge de forme n\u00e9ovasculaire, les \u0153d\u00e8mes maculaires d\u2019origine diab\u00e9tique ou veineuse r\u00e9tinienne, la r\u00e9tinopathie diab\u00e9tique prolif\u00e9rante et certaines n\u00e9ovascularisations choro\u00efdiennes ; et Neuzafy (filgrastim), indiqu\u00e9 dans le traitement de la neutrop\u00e9nie chez l\u2019adulte et l\u2019enfant.<\/p>\n
Le CHMP a par ailleurs recommand\u00e9 l\u2019autorisation de Kizfizo (t\u00e9modalomide) pour le traitement des adultes atteints de glioblastome multiforme et des enfants atteints de gliome malin. Ce m\u00e9dicament fait l\u2019objet d\u2019une demande dite \u00ab hybride \u00bb, reposant \u00e0 la fois sur des donn\u00e9es existantes d\u2019un produit de r\u00e9f\u00e9rence d\u00e9j\u00e0 autoris\u00e9 et sur de nouvelles donn\u00e9es pr\u00e9cliniques et cliniques.<\/p>\n
Le comit\u00e9 a approuv\u00e9 des extensions d\u2019indication pour cinq m\u00e9dicaments d\u00e9j\u00e0 autoris\u00e9s dans l\u2019UE : le vaccin contre la grippe pand\u00e9mique H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza et Tukysa. Le d\u00e9tail des nouvelles indications n\u2019est pas pr\u00e9cis\u00e9 dans la source, mais ces d\u00e9cisions t\u00e9moignent d\u2019un \u00e9largissement des usages th\u00e9rapeutiques au sein du cadre r\u00e9glementaire europ\u00e9en.<\/p>\n
\u00c0 l\u2019issue d\u2019une proc\u00e9dure de r\u00e9examen, le CHMP a confirm\u00e9 sa recommandation de refus d\u2019autorisation de mise sur le march\u00e9 pour Yartemlea (narsoplimab), destin\u00e9 au traitement des adultes et des enfants \u00e0 partir de 2 ans pr\u00e9sentant une thrombose associ\u00e9e \u00e0 une greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (HSCT). Le motif d\u00e9taill\u00e9 du refus n\u2019est pas indiqu\u00e9, mais la d\u00e9cision souligne le maintien de la position initiale du comit\u00e9 apr\u00e8s r\u00e9\u00e9valuation. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a recommand\u00e9, lors de sa r\u00e9union d\u2019octobre 2026, l\u2019approbation de six nouveaux m\u00e9dicaments et l\u2019extension d\u2019indication […]<\/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":[31,2],"tags":[257,227,226],"class_list":["post-21267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politiques-europeennes-sante-social-travail","category-sante-publique-et-systeme-de-soins","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21267","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=21267"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21267\/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=21267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}