{"id":7757,"date":"2025-03-10T11:35:12","date_gmt":"2025-03-10T10:35:12","guid":{"rendered":"https:\/\/smc-news.ch\/?p=7757"},"modified":"2025-03-10T19:04:19","modified_gmt":"2025-03-10T18:04:19","slug":"autorisation-des-therapies-anti-amyloides-no-plain-sailing-etat-au-1-2-2025","status":"publish","type":"post","link":"https:\/\/smc-news.ch\/fr\/autorisation-des-therapies-anti-amyloides-no-plain-sailing-etat-au-1-2-2025\/","title":{"rendered":"Autorisation des th\u00e9rapies anti-amylo\u00efdes- No plain sailing (\u00e9tat au 1.2.2025)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>La proc\u00e9dure d'autorisation de Swissmedic concernant le lecanemab n'est pas encore termin\u00e9e. Mais comment se pr\u00e9sente la situation dans les pays voisins ? <\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">En Europe, un avis positif du CHMP (Committee for Medicinal Products for Human Use) a \u00e9t\u00e9 communiqu\u00e9 le 14.11.2024 pour les personnes atteintes de MCI ou de d\u00e9mence l\u00e9g\u00e8re de type Alzheimer (ApoE4 Non-Carrier et ApoE4 Heterozygote), une d\u00e9cision finale d'autorisation de mise sur le march\u00e9 de la part de l'EMA (European Medicines Agency) \u00e9tait attendue pour le 20.1.2025 - mais est toujours en attente apr\u00e8s l'expiration de ce d\u00e9lai.<\/p>\n\n<p class=\"wp-block-paragraph\">Le 31 janvier 2025, le CHMP a indiqu\u00e9 que la Commission europ\u00e9enne avait pos\u00e9 des questions concernant les donn\u00e9es de s\u00e9curit\u00e9 et la communication relative \u00e0 la r\u00e9duction des risques, et que l'autorisation d\u00e9finitive ne serait discut\u00e9e que lors de la r\u00e9union de f\u00e9vrier 2025. <\/p>\n\n<p class=\"wp-block-paragraph\">En cas de d\u00e9cision positive du CHMP et de l'EMA, on peut s'attendre \u00e0 ce qu'une prise en charge limit\u00e9e \u00e0 12 mois soit d'abord accord\u00e9e en Allemagne.<\/p>\n\n<h4 class=\"wp-block-heading\">Les autorit\u00e9s r\u00e9glementaires de la United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) ont accord\u00e9 l'autorisation de mise sur le march\u00e9 du lecanemab le 22 ao\u00fbt 2024, apr\u00e8s un examen approfondi.<\/h4>\n\n<p class=\"wp-block-paragraph\">Cependant, le National Institute for Health and Care Excellence (NICE) ne recommande pas l'utilisation du lecanemab au NHS (National Health Service) en raison du rapport co\u00fbt-b\u00e9n\u00e9fice. Le traitement par donanemab n'est pas non plus recommand\u00e9 par le NICE, de sorte que seuls les patientes et patients payant eux-m\u00eames leur traitement ont actuellement acc\u00e8s \u00e0 ces m\u00e9dicaments. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>La proc\u00e9dure d&rsquo;autorisation de Swissmedic concernant le lecanemab n&rsquo;est pas encore termin\u00e9e. Mais comment se pr\u00e9sente la situation dans les pays voisins ? En Europe, un avis positif du CHMP (Committee for Medicinal Products for Human Use) a \u00e9t\u00e9 communiqu\u00e9 le 14.11.2024 pour les personnes atteintes de MCI ou de d\u00e9mence l\u00e9g\u00e8re de type Alzheimer [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6772,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[],"post_folder":[],"class_list":["post-7757","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recherche"],"_links":{"self":[{"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/posts\/7757","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/comments?post=7757"}],"version-history":[{"count":3,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/posts\/7757\/revisions"}],"predecessor-version":[{"id":7800,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/posts\/7757\/revisions\/7800"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/media\/6772"}],"wp:attachment":[{"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/media?parent=7757"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/categories?post=7757"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/tags?post=7757"},{"taxonomy":"post_folder","embeddable":true,"href":"https:\/\/smc-news.ch\/fr\/wp-json\/wp\/v2\/post_folder?post=7757"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}