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 de septembre 2026, l\u2019approbation de 12 m\u00e9dicaments, dont plusieurs dans des aires th\u00e9rapeutiques majeures pour les politiques de sant\u00e9.<\/p>\n
En h\u00e9matologie, Frehemgo (denecimig) a re\u00e7u un avis favorable pour la prophylaxie des \u00e9pisodes h\u00e9morragiques chez les patients atteints d\u2019h\u00e9mophilie A, maladie h\u00e9r\u00e9ditaire li\u00e9e \u00e0 un d\u00e9ficit en facteur VIII. En oncologie, plusieurs traitements ont \u00e9t\u00e9 recommand\u00e9s : Gevalka (ensartinib) pour le cancer du poumon non \u00e0 petites cellules avanc\u00e9 positif \u00e0 ALK chez l\u2019adulte ; Lifyorli (relacorilant) pour le traitement des cancers \u00e9pith\u00e9liaux de l\u2019ovaire, des trompes de Fallope ou p\u00e9riton\u00e9aux primaires r\u00e9sistants au platine ; Sepalna (senaparib) en traitement d\u2019entretien des cancers \u00e9pith\u00e9liaux de haut grade de l\u2019ovaire, des trompes de Fallope ou p\u00e9riton\u00e9aux avanc\u00e9s ; Pebrilzo (pertuzumab), biosimilaire destin\u00e9 au traitement du cancer du sein chez l\u2019adulte, premier biosimilaire recommand\u00e9 dans le cadre d\u2019une approche clinique \u00ab sur mesure \u00bb. Ruxolitinib Zentiva (ruxolitinib), g\u00e9n\u00e9rique, a re\u00e7u un avis positif pour le traitement de la my\u00e9lofibrose et de la polyglobulie vraie chez l\u2019adulte, ainsi que dans le cadre de la prise en charge du greffon (indication non pr\u00e9cis\u00e9e dans le texte source).<\/p>\n
En neurologie, Klygefa (gefurulimab) a \u00e9t\u00e9 recommand\u00e9 pour le traitement de la myasth\u00e9nie grave g\u00e9n\u00e9ralis\u00e9e chez l\u2019adulte, maladie entra\u00eenant faiblesse musculaire et fatigabilit\u00e9. En dermatologie, Povofortay (povorcitinib) a re\u00e7u un avis positif pour le traitement de l\u2019hidrad\u00e9nite suppur\u00e9e (acn\u00e9 inversa) active mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re chez l\u2019adulte, premi\u00e8re option de traitement oral quotidien pour les patients r\u00e9fractaires ou intol\u00e9rants aux anti-TNF.<\/p>\n
En maladies infectieuses et vaccination, le CHMP a recommand\u00e9 VaxRabeo, vaccin \u00e0 virus rabique inactiv\u00e9 (souche WISTAR), pour la prophylaxie pr\u00e9- et post-exposition contre la rage chez les personnes de tout \u00e2ge. En pathologie digestive, Zeydovio (glepaglutide) a re\u00e7u un avis favorable pour le traitement du syndrome du gr\u00eale court, caract\u00e9ris\u00e9 par une malabsorption des nutriments et des liquides, g\u00e9n\u00e9ralement apr\u00e8s r\u00e9section \u00e9tendue de l\u2019intestin.<\/p>\n
Deux biosimilaires suppl\u00e9mentaires ont obtenu un avis positif : Adcomfo (omalizumab) pour le traitement de l\u2019asthme, de la rhinosinusite chronique avec polypes nasaux et de l\u2019urticaire chronique spontan\u00e9e, et Pebrilzo (pertuzumab) pour le cancer du sein. Deux g\u00e9n\u00e9riques ont \u00e9galement \u00e9t\u00e9 recommand\u00e9s : Inijaq (tofacitinib) pour le traitement de la polyarthrite rhumato\u00efde, du rhumatisme psoriasique, de la spondylarthrite ankylosante et de la rectocolite h\u00e9morragique chez l\u2019adulte, ainsi que de l\u2019arthrite juv\u00e9nile idiopathique chez l\u2019enfant \u00e0 partir de 2 ans ; et Ruxolitinib Zentiva (ruxolitinib) pour plusieurs h\u00e9mopathies de l\u2019adulte.<\/p>\n
Ces d\u00e9cisions de l\u2019EMA concernent principalement l\u2019Union europ\u00e9enne et s\u2019inscrivent dans le cadre des proc\u00e9dures d\u2019autorisation de mise sur le march\u00e9 europ\u00e9ennes, avec des enjeux pour l\u2019acc\u00e8s aux innovations th\u00e9rapeutiques (notamment en oncologie, dermatologie s\u00e9v\u00e8re, maladies rares et immunologiques) et pour la r\u00e9gulation des d\u00e9penses de sant\u00e9 via l\u2019arriv\u00e9e de biosimilaires et de g\u00e9n\u00e9riques. (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 de septembre 2026, l\u2019approbation de 12 m\u00e9dicaments, dont plusieurs dans […]<\/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-18443","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\/18443","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=18443"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18443\/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=18443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}