{"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&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 ? <\/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&rsquo;autorisation de mise sur le march\u00e9 de la part de l&rsquo;EMA (European Medicines Agency) \u00e9tait attendue pour le 20.1.2025 &#8211; mais est toujours en attente apr\u00e8s l&rsquo;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&rsquo;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&rsquo;EMA, on peut s&rsquo;attendre \u00e0 ce qu&rsquo;une prise en charge limit\u00e9e \u00e0 12 mois soit d&rsquo;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&rsquo;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&rsquo;utilisation du lecanemab au NHS (National Health Service) en raison du rapport co\u00fbt-b\u00e9n\u00e9fice. Le traitement par donanemab n&rsquo;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":{"_et_pb_use_builder":"off","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[27],"tags":[],"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"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}