Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9mis un avis favorable en vue de l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Zeydovio, un m\u00e9dicament destin\u00e9 au traitement du syndrome du gr\u00eale court (Short Bowel Syndrome, SBS) chez l\u2019adulte. La demande d\u2019autorisation a \u00e9t\u00e9 d\u00e9pos\u00e9e par la soci\u00e9t\u00e9 Zealand Pharma A\/S. Apr\u00e8s d\u00e9cision de la Commission europ\u00e9enne, les informations d\u00e9taill\u00e9es d\u2019utilisation seront publi\u00e9es dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP\/SmPC) sur le site de l\u2019EMA, dans toutes les langues officielles de l\u2019Union europ\u00e9enne.<\/p>\n
Zeydovio sera disponible sous forme de solution injectable \u00e0 10 mg en stylo pr\u00e9rempli. La substance active est le glepaglutide, class\u00e9 parmi les m\u00e9dicaments de l\u2019appareil digestif et du m\u00e9tabolisme (code ATC A16AX26). Il s\u2019agit d\u2019un analogue de longue dur\u00e9e d\u2019action du GLP\u20112, peptide \u00e0 propri\u00e9t\u00e9s intestinotrophes qui augmente le flux sanguin intestinal et portal, diminue la s\u00e9cr\u00e9tion acide gastrique et la motricit\u00e9 intestinale, et favorise la croissance normale de la muqueuse intestinale (augmentation de l\u2019\u00e9paisseur de la muqueuse, de la hauteur de l\u2019\u00e9pith\u00e9lium intestinal et de la profondeur des cryptes).<\/p>\n
Le principal b\u00e9n\u00e9fice mis en avant est la r\u00e9duction des besoins des patients en support parent\u00e9ral. Dans les donn\u00e9es examin\u00e9es par le CHMP, une administration deux fois par semaine pendant 24 semaines de glepaglutide a entra\u00een\u00e9 une diminution plus importante du volume hebdomadaire de support parent\u00e9ral par rapport au placebo. Le m\u00e9dicament est indiqu\u00e9 pour les adultes pr\u00e9sentant un SBS, \u00e0 condition qu\u2019ils soient cliniquement stables apr\u00e8s une phase d\u2019adaptation intestinale cons\u00e9cutive \u00e0 une chirurgie. Le traitement doit \u00eatre initi\u00e9 sous la supervision d\u2019un professionnel de sant\u00e9 exp\u00e9riment\u00e9 dans la prise en charge du SBS.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quemment rapport\u00e9s sont des r\u00e9actions au site d\u2019injection, des complications digestives li\u00e9es \u00e0 la stomie chez les patients stomis\u00e9s, des douleurs et distensions abdominales, des naus\u00e9es, une r\u00e9tention hydrique ou une surcharge en fluides, ainsi que des vomissements. Ces \u00e9l\u00e9ments, qui figureront dans le RCP, sont susceptibles d\u2019avoir des implications pour l\u2019organisation de la prise en charge sp\u00e9cialis\u00e9e et la surveillance clinique des patients adultes atteints de syndrome du gr\u00eale court dans les syst\u00e8mes de sant\u00e9 des \u00c9tats membres. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9mis un avis favorable en vue de l\u2019octroi d\u2019une autorisation de […]<\/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-17903","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\/17903","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=17903"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17903\/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=17903"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17903"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17903"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}