La Commission europ\u00e9enne a retir\u00e9 le 4 ao\u00fbt 2026 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Tavneos 10 mg, g\u00e9lule (avacopan), dans l\u2019Union europ\u00e9enne, \u00e0 la suite d\u2019une recommandation de l\u2019Agence europ\u00e9enne du m\u00e9dicament (EMA). Cette d\u00e9cision repose sur une r\u00e9\u00e9valuation des donn\u00e9es de l\u2019\u00e9tude clinique ayant soutenu l\u2019AMM, qui ne permet plus de d\u00e9montrer un b\u00e9n\u00e9fice suffisant au regard des risques h\u00e9patiques graves connus. Tavneos, autoris\u00e9 par proc\u00e9dure centralis\u00e9e depuis le 11 janvier 2022 et exploit\u00e9 en France par Vifor Fresenius Medical Care Renal Pharma France, \u00e9tait indiqu\u00e9 chez l\u2019adulte dans certaines maladies inflammatoires rares des vaisseaux sanguins. Environ 600 patients \u00e9taient trait\u00e9s en France.<\/p>\n
En anticipation de ce retrait, une lettre aux professionnels de sant\u00e9 a \u00e9t\u00e9 diffus\u00e9e le 16 juillet 2026 pour demander l\u2019arr\u00eat de toute nouvelle initiation de traitement par Tavneos, l\u2019orientation des patients d\u00e9j\u00e0 trait\u00e9s vers des alternatives appropri\u00e9es et le renforcement de la surveillance h\u00e9patique. \u00c0 la suite de la d\u00e9cision europ\u00e9enne, le laboratoire exploitant Vifor France d\u00e9clenche, \u00e0 compter du 19 ao\u00fbt 2026, le rappel de tous les lots de Tavneos 10 mg, g\u00e9lule encore disponibles sur le territoire fran\u00e7ais.<\/p>\n
Des consignes sp\u00e9cifiques sont formul\u00e9es pour les diff\u00e9rents acteurs. Les patients sont invit\u00e9s \u00e0 ne pas interrompre d\u2019eux-m\u00eames leur traitement, \u00e0 contacter rapidement leur m\u00e9decin prescripteur pour envisager une alternative th\u00e9rapeutique et \u00e0 consulter imm\u00e9diatement en cas de sympt\u00f4mes \u00e9voquant une atteinte h\u00e9patique (fatigue, naus\u00e9es, ict\u00e8re, douleurs abdominales). Les m\u00e9decins ne doivent initier aucun nouveau traitement ni renouveler Tavneos et doivent, si ce n\u2019est d\u00e9j\u00e0 fait, organiser dans les meilleurs d\u00e9lais le report des patients vers d\u2019autres options th\u00e9rapeutiques, en \u00e9vitant un arr\u00eat brutal sans relais afin de ne pas aggraver la pathologie. Les pharmaciens d\u2019officine et hospitaliers doivent informer les patients encore trait\u00e9s de la n\u00e9cessit\u00e9 de consulter leur prescripteur sans arr\u00eater spontan\u00e9ment le m\u00e9dicament et ne plus d\u00e9livrer Tavneos en cas de demande de renouvellement. Ces mesures s\u2019inscrivent dans un cadre europ\u00e9en de gestion du risque m\u00e9dicamenteux impliquant la Commission europ\u00e9enne, l\u2019EMA et le laboratoire exploitant, avec des implications directes pour la continuit\u00e9 et la s\u00e9curit\u00e9 de la prise en charge de patients atteints de maladies rares en France.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" La Commission europ\u00e9enne a retir\u00e9 le 4 ao\u00fbt 2026 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Tavneos 10 mg, g\u00e9lule (avacopan), dans l\u2019Union europ\u00e9enne, \u00e0 la suite d\u2019une […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"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 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