{"id":167160,"date":"2025-12-22T16:16:50","date_gmt":"2025-12-22T21:16:50","guid":{"rendered":"https:\/\/wfh.org\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/"},"modified":"2026-01-20T12:15:17","modified_gmt":"2026-01-20T17:15:17","slug":"declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/","title":{"rendered":"D\u00e9claration de la FMH et de la NBDF sur les effets ind\u00e9sirables graves de l&rsquo;agent de r\u00e9\u00e9quilibrage marstacimab pour l&rsquo;h\u00e9mophilie"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"167160\" class=\"elementor elementor-167160 elementor-166323\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3b65868 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b65868\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1bff81a\" data-id=\"1bff81a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-29b2ac3 elementor-widget elementor-widget-text-editor\" data-id=\"29b2ac3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La thrombose est un effet ind\u00e9sirable d\u2019int\u00e9r\u00eat particulier dans le cas du marstacimab, dont le m\u00e9canisme d\u2019action en fait un agent de r\u00e9\u00e9quilibrage qui cible l\u2019inhibiteur de la voie du facteur tissulaire (TFPI), afin d\u2019augmenter la production de thrombine et favoriser la cr\u00e9ation de caillots. Des \u00e9v\u00e9nements thrombotiques ont \u00e9t\u00e9 observ\u00e9s avec d\u2019autres th\u00e9rapies non substitutives de l\u2019h\u00e9mophilie. L\u2019utilisation du marstacimab doit inclure une surveillance attentive des sympt\u00f4mes de thrombose et d\u2019autres effets ind\u00e9sirables, en particulier en contexte chirurgical et en association avec des concentr\u00e9s de facteur de coagulation ou des agents de contournement.<\/p>\n<p>Le marstacimab a \u00e9t\u00e9 approuv\u00e9 par la Food and Drug Administration (FDA) des \u00c9tats-Unis en octobre 2024, puis par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) en novembre 2024, pour la prophylaxie de routine chez les adultes et les adolescent\u00b7es de 12 ans et plus qui sont atteint\u00b7es d\u2019h\u00e9mophilie A ou B s\u00e9v\u00e8re sans inhibiteurs. Le marstacimab est actuellement approuv\u00e9 aux \u00c9tats-Unis, dans les 27 \u00c9tats membres de l\u2019Union europ\u00e9enne, en Islande, au Liechtenstein, en Norv\u00e8ge, au Royaume-Uni, en Suisse, en Australie et \u00e0 Singapour.<\/p>\n<p>La FMH et la NBDF suivent de pr\u00e8s les \u00e9volutions relatives \u00e0 cet \u00e9v\u00e9nement et tiendront la communaut\u00e9 inform\u00e9e de ses suites d\u00e8s que possible.<\/p>\n<p>Vous pouvez consulter la lettre de Pfizer sur l\u2019effet ind\u00e9sirable li\u00e9 au marstacimab publi\u00e9e le 22 d\u00e9cembre 2025\u00a0<a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/12\/Letter_Marstacimab-Serious-Adverse-Event_12.22.2025.pdf\" target=\"_blank\" rel=\"noopener\">ici<\/a> (en anglais). Pour obtenir une version PDF de la pr\u00e9sente d\u00e9claration, cliquez\u00a0<a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/12\/WFH-NBDF-Statement-on-Marstacimab-Thrombotic-Event-12-22-2025_Final.pdf\" target=\"_blank\" rel=\"noopener\">ici<\/a>.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>La F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) et la National Bleeding Disorders Foundation (NBDF) ont \u00e9t\u00e9 inform\u00e9es par Pfizer d\u2019un effet ind\u00e9sirable grave survenu le 14 d\u00e9cembre chez un individu sous prophylaxie par marstacimab (Hympavzi\u00ae), qui a \u00e9t\u00e9 victime d\u2019un accident vasculaire c\u00e9r\u00e9bral fatal apr\u00e8s une intervention chirurgicale mineure. Cette personne atteinte d\u2019h\u00e9mophilie A avec inhibiteurs actifs, qui participait au programme d\u2019essai clinique de Pfizer sur le marstacimab, \u00e9tait sous prophylaxie par marstacimab \u00e0 la dose d\u2019entretien (une dose de 150 mg par semaine) depuis trois ans. L\u2019AVC s\u2019est produit dans le cadre de l\u2019\u00e9tude de prolongation ouverte. Pfizer recueille activement des informations pour \u00e9clairer les liens de causalit\u00e9 avec l\u2019\u00e9v\u00e9nement. Le marstacimab n\u2019est pas encore approuv\u00e9 par les autorit\u00e9s de r\u00e9glementation pour le traitement de l\u2019h\u00e9mophilie avec inhibiteurs et reste en cours d\u2019investigation clinique.<\/p>\n","protected":false},"author":13,"featured_media":166319,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[197,336],"tags":[],"search-category":[85],"class_list":["post-167160","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declarations-publiques-et-recommandations-de-la-fmh","category-featured-2-fr","search-category-article"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>D\u00e9claration de la FMH et de la NBDF sur les effets ind\u00e9sirables graves de l&#039;agent de r\u00e9\u00e9quilibrage marstacimab pour l&#039;h\u00e9mophilie | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"D\u00e9claration de la FMH et de la NBDF sur les effets ind\u00e9sirables graves de l&#039;agent de r\u00e9\u00e9quilibrage marstacimab pour l&#039;h\u00e9mophilie\" \/>\n<meta property=\"og:description\" content=\"La F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) et la National Bleeding Disorders Foundation (NBDF) ont \u00e9t\u00e9 inform\u00e9es par Pfizer d\u2019un effet ind\u00e9sirable grave survenu le 14 d\u00e9cembre chez un individu sous prophylaxie par marstacimab (Hympavzi\u00ae), qui a \u00e9t\u00e9 victime d\u2019un accident vasculaire c\u00e9r\u00e9bral fatal apr\u00e8s une intervention chirurgicale mineure. Cette personne atteinte d\u2019h\u00e9mophilie A avec inhibiteurs actifs, qui participait au programme d\u2019essai clinique de Pfizer sur le marstacimab, \u00e9tait sous prophylaxie par marstacimab \u00e0 la dose d\u2019entretien (une dose de 150 mg par semaine) depuis trois ans. L\u2019AVC s\u2019est produit dans le cadre de l\u2019\u00e9tude de prolongation ouverte. Pfizer recueille activement des informations pour \u00e9clairer les liens de causalit\u00e9 avec l\u2019\u00e9v\u00e9nement. Le marstacimab n\u2019est pas encore approuv\u00e9 par les autorit\u00e9s de r\u00e9glementation pour le traitement de l\u2019h\u00e9mophilie avec inhibiteurs et reste en cours d\u2019investigation clinique.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-22T21:16:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-20T17:15:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/12\/WFH-and-NBDF-joint-statement-FR.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mitch Semienchuk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mitch Semienchuk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/\"},\"author\":{\"name\":\"Mitch Semienchuk\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/4aea5b13c1966452a640eef39423925b\"},\"headline\":\"D\u00e9claration de la FMH et de la NBDF sur les effets ind\u00e9sirables graves de l&rsquo;agent de r\u00e9\u00e9quilibrage marstacimab pour l&rsquo;h\u00e9mophilie\",\"datePublished\":\"2025-12-22T21:16:50+00:00\",\"dateModified\":\"2026-01-20T17:15:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/\"},\"wordCount\":295,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/12\/WFH-and-NBDF-joint-statement-FR.jpg\",\"articleSection\":[\"D\u00e9clarations publiques et recommandations de la FMH\",\"Featured 2 - 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F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/wfh.org\/fr\/article\/declaration-de-la-fmh-et-de-la-nbdf-sur-les-effets-indesirables-graves-de-lagent-de-reequilibrage-marstacimab-pour-lhemophilie\/","og_locale":"fr_FR","og_type":"article","og_title":"D\u00e9claration de la FMH et de la NBDF sur les effets ind\u00e9sirables graves de l'agent de r\u00e9\u00e9quilibrage marstacimab pour l'h\u00e9mophilie","og_description":"La F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) et la National Bleeding Disorders Foundation (NBDF) ont \u00e9t\u00e9 inform\u00e9es par Pfizer d\u2019un effet ind\u00e9sirable grave survenu le 14 d\u00e9cembre chez un individu sous prophylaxie par marstacimab (Hympavzi\u00ae), qui a \u00e9t\u00e9 victime d\u2019un accident vasculaire c\u00e9r\u00e9bral fatal apr\u00e8s une intervention chirurgicale mineure. Cette personne atteinte d\u2019h\u00e9mophilie A avec inhibiteurs actifs, qui participait au programme d\u2019essai clinique de Pfizer sur le marstacimab, \u00e9tait sous prophylaxie par marstacimab \u00e0 la dose d\u2019entretien (une dose de 150 mg par semaine) depuis trois ans. L\u2019AVC s\u2019est produit dans le cadre de l\u2019\u00e9tude de prolongation ouverte. Pfizer recueille activement des informations pour \u00e9clairer les liens de causalit\u00e9 avec l\u2019\u00e9v\u00e9nement. 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