{"id":18925,"date":"2026-09-25T08:38:01","date_gmt":"2026-09-25T08:38:01","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=18925"},"modified":"2026-09-25T08:38:01","modified_gmt":"2026-09-25T08:38:01","slug":"rapport-europeen-public-devaluation-pour-les-medicaments-a-usage-humain-epar-skytrofa-anciennement-lonapegsomatropin-ascendis-pharma-lonapegsomatropine-date-dautorisation-1","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=18925","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation pour les m\u00e9dicaments \u00e0 usage humain (EPAR) : Skytrofa (anciennement Lonapegsomatropin Ascendis Pharma), lonapegsomatropine, Date d\u2019autorisation : 11\/01\/2022, R\u00e9vision : 7, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Lonapegsomatropin Ascendis Pharma est un m\u00e9dicament destin\u00e9 \u00e0 am\u00e9liorer la croissance chez les enfants et adolescents de 3 \u00e0 18 ans pr\u00e9sentant un d\u00e9ficit en hormone de croissance (GHD). Il contient la substance active lonapegsomatropine, une forme de somatropine humaine li\u00e9e \u00e0 un vecteur qui permet une lib\u00e9ration lente de l\u2019hormone de croissance apr\u00e8s injection et \u00e9vite des injections quotidiennes. Le traitement est soumis \u00e0 prescription m\u00e9dicale et doit \u00eatre initi\u00e9 et suivi par un m\u00e9decin exp\u00e9riment\u00e9 dans le diagnostic et la prise en charge du GHD p\u00e9diatrique. Le m\u00e9dicament est administr\u00e9 par injection sous-cutan\u00e9e une fois par semaine, \u00e0 des dosages variables en fonction du poids corporel, ensuite ajust\u00e9s individuellement. Apr\u00e8s formation, les patients ou leurs aidants peuvent r\u00e9aliser eux\u2011m\u00eames les injections.<\/p>\n<p>Le GHD \u00e9tant une pathologie rare, Lonapegsomatropin Ascendis Pharma a obtenu le statut de m\u00e9dicament orphelin le 17 octobre 2019 au niveau europ\u00e9en, dans le cadre de la proc\u00e9dure coordonn\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA). Des informations compl\u00e9mentaires sur cette d\u00e9signation orpheline sont disponibles sur le site de l\u2019EMA.<\/p>\n<p>L\u2019efficacit\u00e9 de Lonapegsomatropin Ascendis Pharma administr\u00e9 une fois par semaine \u00e0 des doses \u00e9quivalentes \u00e0 la somatropine quotidienne a \u00e9t\u00e9 d\u00e9montr\u00e9e dans une \u00e9tude principale portant sur 161 enfants de 3 \u00e0 12 ans atteints de GHD non trait\u00e9 auparavant. La vitesse de croissance annuelle moyenne au bout d\u2019un an \u00e9tait de 11,2 cm\/an dans le groupe lonapegsomatropine, contre 10,3 cm\/an dans le groupe somatropine quotidienne, alors que la vitesse de croissance moyenne avant traitement \u00e9tait de 3,9 cm\/an dans les deux groupes. Le laboratoire a \u00e9galement pr\u00e9sent\u00e9 des \u00e9tudes de soutien incluant des patients d\u00e9j\u00e0 trait\u00e9s auparavant par hormone de croissance.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (jusqu\u2019\u00e0 1 patient sur 10 environ) sont des c\u00e9phal\u00e9es, des douleurs articulaires, une hypothyro\u00efdie secondaire et des r\u00e9actions au site d\u2019injection (rougeur, douleur, prurit, gonflement). Les m\u00e9dicaments \u00e0 base d\u2019hormone de croissance comme Lonapegsomatropin Ascendis Pharma ne doivent pas \u00eatre utilis\u00e9s chez des patients pr\u00e9sentant une tumeur active ou une affection aigu\u00eb mettant en jeu le pronostic vital. La liste compl\u00e8te des effets ind\u00e9sirables et les modalit\u00e9s pratiques d\u2019utilisation figurent dans la notice destin\u00e9e aux patients. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/skytrofa\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Lonapegsomatropin Ascendis Pharma est un m\u00e9dicament destin\u00e9 \u00e0 am\u00e9liorer la croissance chez les enfants et adolescents de 3 \u00e0 18 ans pr\u00e9sentant un d\u00e9ficit en hormone de croissance (GHD). Il [&hellip;]<\/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-18925","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\/18925","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=18925"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18925\/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=18925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}