La Commission europ\u00e9enne a retir\u00e9, \u00e0 compter du 1er janvier 2026, l\u2019autorisation de mise sur le march\u00e9 de Bydureon (ex\u00e9natide) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du titulaire de l\u2019autorisation de mise sur le march\u00e9, AstraZeneca AB, qui a notifi\u00e9 \u00e0 la Commission sa d\u00e9cision d\u2019arr\u00eater d\u00e9finitivement la commercialisation du produit pour des raisons commerciales. Aucun autre motif n\u2019est mentionn\u00e9 dans la source.<\/p>\n
Bydureon avait obtenu une autorisation de mise sur le march\u00e9 dans l\u2019UE le 17 juin 2011, avec une validit\u00e9 devenue illimit\u00e9e en 2016. Il s\u2019agit d\u2019un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte de 18 ans et plus atteint de diab\u00e8te de type 2, appartenant au groupe pharmacoth\u00e9rapeutique des m\u00e9dicaments utilis\u00e9s dans le diab\u00e8te (code A10BJ01). Il \u00e9tait destin\u00e9 \u00e0 l\u2019am\u00e9lioration du contr\u00f4le glyc\u00e9mique lorsque le traitement en cours, associ\u00e9 au r\u00e9gime alimentaire et \u00e0 l\u2019exercice, ne permettait pas un contr\u00f4le suffisant.<\/p>\n
Le m\u00e9dicament \u00e9tait utilis\u00e9 en association avec d\u2019autres traitements hypoglyc\u00e9miants oraux, notamment la metformine, les sulfamides hypoglyc\u00e9miants (sulfonylur\u00e9es), les thiazolidinediones, ou des combinaisons de metformine avec sulfonylur\u00e9e ou avec thiazolidinedione, chez des adultes n\u2019ayant pas atteint un contr\u00f4le glyc\u00e9mique satisfaisant malgr\u00e9 les doses maximales tol\u00e9r\u00e9es de ces traitements.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont la Commission europ\u00e9enne, qui prend la d\u00e9cision formelle de retrait de l\u2019autorisation de mise sur le march\u00e9 au niveau de l\u2019UE, et AstraZeneca AB, en tant que titulaire de l\u2019autorisation et \u00e0 l\u2019origine de la demande de retrait pour motif commercial. L\u2019information pr\u00e9sente un int\u00e9r\u00eat pour le suivi des options th\u00e9rapeutiques disponibles pour le diab\u00e8te de type 2 dans l\u2019UE, sans qu\u2019aucune cons\u00e9quence sp\u00e9cifique pour les politiques nationales de sant\u00e9 ne soit pr\u00e9cis\u00e9e dans la source. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" La Commission europ\u00e9enne a retir\u00e9, \u00e0 compter du 1er janvier 2026, l\u2019autorisation de mise sur le march\u00e9 de Bydureon (ex\u00e9natide) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du […]<\/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-19717","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\/19717","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=19717"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19717\/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=19717"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19717"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}