Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis positif recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Neuzafy, un m\u00e9dicament destin\u00e9 au traitement de la neutrop\u00e9nie et \u00e0 la mobilisation des cellules prog\u00e9nitrices h\u00e9matopo\u00ef\u00e9tiques p\u00e9riph\u00e9riques (PBPC). Le demandeur est CuraTeQ Biologics (Malta) Limited. La d\u00e9cision finale rel\u00e8ve de la Commission europ\u00e9enne.<\/p>\n
Neuzafy contient comme substance active le filgrastim, facteur de stimulation des colonies de granulocytes (G-CSF) recombinant, class\u00e9 comme immunostimulant (code ATC L03AA02). Il sera disponible en solution injectable\/pour perfusion \u00e0 30 MU\/0,5 ml et 48 MU\/0,5 ml. Le m\u00e9dicament est pr\u00e9sent\u00e9 comme un biosimilaire du produit de r\u00e9f\u00e9rence Neupogen (filgrastim), d\u00e9j\u00e0 autoris\u00e9 dans plusieurs \u00c9tats membres de l\u2019UE, avec des donn\u00e9es montrant une qualit\u00e9, une s\u00e9curit\u00e9 et une efficacit\u00e9 comparables.<\/p>\n
Les indications approuv\u00e9es par le CHMP couvrent plusieurs situations cliniques li\u00e9es \u00e0 la neutrop\u00e9nie. Neuzafy est indiqu\u00e9 pour r\u00e9duire la dur\u00e9e de la neutrop\u00e9nie et l\u2019incidence de la neutrop\u00e9nie f\u00e9brile chez les patients recevant une chimioth\u00e9rapie cytotoxique \u00e9tablie pour une affection maligne, \u00e0 l\u2019exception de la leuc\u00e9mie my\u00e9lo\u00efde chronique et des syndromes my\u00e9lodysplasiques. Il est \u00e9galement indiqu\u00e9 pour r\u00e9duire la dur\u00e9e de la neutrop\u00e9nie chez les patients soumis \u00e0 un traitement my\u00e9loablatif suivi d\u2019une greffe de moelle osseuse, consid\u00e9r\u00e9s \u00e0 risque \u00e9lev\u00e9 de neutrop\u00e9nie s\u00e9v\u00e8re prolong\u00e9e. La s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 sont jug\u00e9es similaires chez l\u2019adulte et l\u2019enfant recevant une chimioth\u00e9rapie cytotoxique.<\/p>\n
Neuzafy est en outre indiqu\u00e9 pour la mobilisation des PBPC. Chez les patients, enfants ou adultes, pr\u00e9sentant une neutrop\u00e9nie s\u00e9v\u00e8re cong\u00e9nitale, cyclique ou idiopathique, avec un compte absolu de neutrophiles (CAN) \u2264 0,5 x 10\u2079\/L et des ant\u00e9c\u00e9dents d\u2019infections s\u00e9v\u00e8res ou r\u00e9currentes, une administration au long cours est indiqu\u00e9e afin d\u2019augmenter le nombre de neutrophiles et de r\u00e9duire l\u2019incidence et la dur\u00e9e des \u00e9v\u00e9nements infectieux. Enfin, Neuzafy est indiqu\u00e9 dans le traitement de la neutrop\u00e9nie persistante (CAN \u2264 1 x 10\u2079\/L) chez les patients atteints d\u2019une infection \u00e0 VIH avanc\u00e9e, afin de r\u00e9duire le risque d\u2019infections bact\u00e9riennes lorsque les autres options de prise en charge de la neutrop\u00e9nie sont inadapt\u00e9es.<\/p>\n
Le m\u00e9dicament doit \u00eatre prescrit et administr\u00e9 par des m\u00e9decins exp\u00e9riment\u00e9s en oncologie et en h\u00e9matologie. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation figureront dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit, qui sera publi\u00e9 sur le site de l\u2019EMA dans toutes les langues officielles de l\u2019Union europ\u00e9enne apr\u00e8s l\u2019octroi de l\u2019autorisation par la Commission europ\u00e9enne. Cette d\u00e9cision s\u2019inscrit dans le cadre de la politique europ\u00e9enne de d\u00e9veloppement et de mise \u00e0 disposition de biosimilaires, avec des enjeux potentiels en mati\u00e8re d\u2019acc\u00e8s aux traitements et de soutenabilit\u00e9 des d\u00e9penses de sant\u00e9 pour les \u00c9tats membres. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis positif recommandant l\u2019octroi d\u2019une autorisation de mise sur le […]<\/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-21271","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\/21271","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=21271"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21271\/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=21271"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21271"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21271"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}