Au 1er janvier 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 de Byetta (ex\u00e9natide) dans l\u2019Union europ\u00e9enne, \u00e0 la demande du titulaire de l\u2019autorisation, la soci\u00e9t\u00e9 AstraZeneca AB (Su\u00e8de). AstraZeneca a notifi\u00e9 \u00e0 la Commission sa d\u00e9cision d\u2019arr\u00eater d\u00e9finitivement la commercialisation de ce m\u00e9dicament pour des raisons commerciales. L\u2019autorisation de mise sur le march\u00e9 avait \u00e9t\u00e9 accord\u00e9e le 20 novembre 2006 et rendue \u00e0 validit\u00e9 illimit\u00e9e en 2016. Le retrait met fin \u00e0 la disponibilit\u00e9 de ce m\u00e9dicament dans l\u2019UE \u00e0 compter de la date effective du 1er janvier 2026.<\/p>\n
Byetta, dont la derni\u00e8re proc\u00e9dure ayant affect\u00e9 l\u2019information produit est r\u00e9f\u00e9renc\u00e9e IA\/008205\/11\/2024, appartenait au groupe pharmacoth\u00e9rapeutique des m\u00e9dicaments utilis\u00e9s dans le diab\u00e8te (code ATC A10BJ01). Il \u00e9tait indiqu\u00e9, chez l\u2019adulte atteint de diab\u00e8te de type 2 insuffisamment contr\u00f4l\u00e9, en association avec la metformine, les sulfamides hypoglyc\u00e9miants, les thiazolidinediones, ou des associations de ces traitements (metformine + sulfamide, metformine + thiazolidinedione), \u00e0 la dose maximale tol\u00e9r\u00e9e de ces antidiab\u00e9tiques oraux. Byetta \u00e9tait \u00e9galement indiqu\u00e9 en traitement adjuvant \u00e0 l\u2019insuline basale, avec ou sans metformine et\/ou pioglitazone, chez des adultes n\u2019ayant pas atteint un contr\u00f4le glyc\u00e9mique satisfaisant avec ces m\u00e9dicaments.<\/p>\n
Plusieurs instances europ\u00e9ennes sont mentionn\u00e9es dans l\u2019historique d\u2019\u00e9valuation du produit, notamment le Comit\u00e9 d\u2019\u00e9valuation des risques en pharmacovigilance (PRAC) et le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA). Ces comit\u00e9s ont suivi et discut\u00e9, \u00e0 diff\u00e9rentes dates (2012, 2013, 2024), les questions de s\u00e9curit\u00e9 li\u00e9es aux agonistes des r\u00e9cepteurs du GLP\u20111, classe th\u00e9rapeutique \u00e0 laquelle appartient l\u2019ex\u00e9natide, dont des investigations sur les risques pancr\u00e9atiques associ\u00e9s aux th\u00e9rapies antidiab\u00e9tiques bas\u00e9es sur le GLP\u20111. Le document mentionne en particulier une revue en cours des agonistes des r\u00e9cepteurs GLP\u20111 et la conclusion d\u2019une investigation sur ces th\u00e9rapies, sans d\u00e9tailler les r\u00e9sultats.<\/p>\n
Les informations disponibles insistent sur le fait que le retrait de Byetta est motiv\u00e9 par des consid\u00e9rations commerciales et non par une d\u00e9cision explicite li\u00e9e \u00e0 la s\u00e9curit\u00e9 ou \u00e0 l\u2019efficacit\u00e9 mentionn\u00e9e dans ce texte. Aucun impact sp\u00e9cifique sur les syst\u00e8mes de sant\u00e9 nationaux ou sur l\u2019organisation des prises en charge du diab\u00e8te n\u2019est d\u00e9taill\u00e9, mais la disparition de ce m\u00e9dicament de l\u2019arsenal th\u00e9rapeutique de l\u2019UE \u00e0 compter de 2026 est clairement act\u00e9e. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Au 1er janvier 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 de Byetta (ex\u00e9natide) dans l\u2019Union europ\u00e9enne, \u00e0 la demande du titulaire de l\u2019autorisation, la soci\u00e9t\u00e9 […]<\/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-19716","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\/19716","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=19716"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19716\/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=19716"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19716"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19716"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}