Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Yuviwel, un nouveau m\u00e9dicament destin\u00e9 au traitement de l\u2019achondroplasie chez l\u2019enfant. Le demandeur est le laboratoire Ascendis Pharma Growth Disorders A\/S. La d\u00e9cision finale rel\u00e8ve de la Commission europ\u00e9enne.<\/p>\n
Yuviwel sera disponible sous forme de poudre et solvant pour solution injectable \u00e0 des dosages de 1,3 mg, 2,8 mg et 5,5 mg. La substance active est le navepegritide, un prom\u00e9dicament contenant un peptide natriur\u00e9tique de type C (CNP), class\u00e9 dans le groupe ATC M05BD02 (traitement des maladies osseuses). Le CNP lib\u00e9r\u00e9 se fixe sur le r\u00e9cepteur NPR\u2011B et favorise la diff\u00e9renciation et la prolif\u00e9ration des chondrocytes, stimulant ainsi la croissance osseuse.<\/p>\n
L\u2019indication retenue est le traitement de l\u2019achondroplasie chez les enfants \u00e2g\u00e9s de 2 ans et plus dont les \u00e9piphyses ne sont pas ferm\u00e9es, avec une confirmation diagnostique par test g\u00e9n\u00e9tique appropri\u00e9. La prescription et le suivi doivent \u00eatre assur\u00e9s par des m\u00e9decins exp\u00e9riment\u00e9s dans le diagnostic et la prise en charge de l\u2019achondroplasie chez l\u2019enfant.<\/p>\n
L\u2019efficacit\u00e9 de Yuviwel repose sur un essai randomis\u00e9, en double insu, contr\u00f4l\u00e9 contre placebo, d\u2019une dur\u00e9e de 52 semaines, montrant une am\u00e9lioration de la vitesse de croissance annualis\u00e9e de 1,49 cm par an par rapport au placebo. Les effets ind\u00e9sirables les plus fr\u00e9quents sont des r\u00e9actions au site d\u2019injection et une hypertrichose (pilosit\u00e9 anormale, y compris au point d\u2019injection).<\/p>\n
Yuviwel a b\u00e9n\u00e9fici\u00e9 du statut de m\u00e9dicament orphelin, ce qui signifie qu\u2019il a \u00e9t\u00e9 d\u00e9velopp\u00e9 pour une maladie rare, potentiellement mortelle ou chroniquement invalidante, ou pour laquelle le d\u00e9veloppement n\u2019aurait probablement pas eu lieu sans incitations sp\u00e9cifiques. L\u2019EMA va r\u00e9examiner les donn\u00e9es disponibles afin de d\u00e9terminer si cette d\u00e9signation orpheline peut \u00eatre maintenue apr\u00e8s l\u2019autorisation de mise sur le march\u00e9. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation figureront dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) qui sera publi\u00e9 sur le site de l\u2019EMA dans toutes les langues officielles de l\u2019Union europ\u00e9enne apr\u00e8s la d\u00e9cision de la Commission. (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 (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur […]<\/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-21273","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\/21273","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=21273"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21273\/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=21273"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21273"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}