Le 17 septembre, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Inijaq, m\u00e9dicament destin\u00e9 au traitement de plusieurs maladies inflammatoires : polyarthrite rhumato\u00efde, arthrite psoriasique, spondylarthrite ankylosante, rectocolite h\u00e9morragique et arthrite juv\u00e9nile idiopathique. Le titulaire de la demande est le laboratoire Gedeon Richter Plc.<\/p>\n
Inijaq sera disponible sous forme de comprim\u00e9s pellicul\u00e9s de 5 mg. Sa substance active est le tofacitinib, immunosuppresseur inhibiteur de Janus kinases (JAK), agissant principalement sur JAK1 et JAK3 et modulant la signalisation de plusieurs interleukines et interf\u00e9rons impliqu\u00e9s dans la r\u00e9ponse immunitaire et inflammatoire. Inijaq est un g\u00e9n\u00e9rique de Xeljanz, autoris\u00e9 dans l\u2019Union europ\u00e9enne depuis le 22 mars 2017. Les \u00e9tudes fournies montrent une qualit\u00e9 jug\u00e9e satisfaisante et une bio\u00e9quivalence avec Xeljanz.<\/p>\n
Le tofacitinib est indiqu\u00e9, chez l\u2019adulte, en association au m\u00e9thotrexate pour le traitement de la polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re et de l\u2019arthrite psoriasique lorsque la r\u00e9ponse \u00e0 un ou plusieurs DMARD (m\u00e9dicaments antirhumatismaux modificateurs de la maladie) a \u00e9t\u00e9 insuffisante ou en cas d\u2019intol\u00e9rance. Il peut \u00eatre utilis\u00e9 en monoth\u00e9rapie en cas d\u2019intol\u00e9rance au m\u00e9thotrexate ou lorsque celui-ci est inappropri\u00e9. Il est \u00e9galement indiqu\u00e9 chez l\u2019adulte dans la spondylarthrite ankylosante active apr\u00e8s \u00e9chec d\u2019un traitement conventionnel, ainsi que dans la rectocolite h\u00e9morragique mod\u00e9r\u00e9ment \u00e0 s\u00e9v\u00e8rement active, apr\u00e8s \u00e9chec, perte de r\u00e9ponse ou intol\u00e9rance \u00e0 un traitement conventionnel ou \u00e0 un biom\u00e9dicament.<\/p>\n
Chez l\u2019enfant \u00e0 partir de 2 ans, le tofacitinib est indiqu\u00e9 dans le traitement de l\u2019arthrite juv\u00e9nile idiopathique polyarticulaire (polyarthrite facteur rhumato\u00efde positif ou n\u00e9gatif et oligoarthrite \u00e9tendue) et de l\u2019arthrite juv\u00e9nile psoriasique, en cas de r\u00e9ponse insuffisante \u00e0 une pr\u00e9c\u00e9dente th\u00e9rapie par DMARD. Il peut \u00eatre administr\u00e9 en association avec le m\u00e9thotrexate ou en monoth\u00e9rapie si le m\u00e9thotrexate est mal tol\u00e9r\u00e9 ou ne peut \u00eatre poursuivi.<\/p>\n
Le traitement par Inijaq doit \u00eatre initi\u00e9 et surveill\u00e9 par des m\u00e9decins sp\u00e9cialistes exp\u00e9riment\u00e9s dans le diagnostic et la prise en charge de ces pathologies. Cette d\u00e9cision du CHMP s\u2019inscrit dans le cadre de la r\u00e9gulation europ\u00e9enne des m\u00e9dicaments et peut avoir des implications en termes d\u2019acc\u00e8s \u00e0 des alternatives g\u00e9n\u00e9riques pour des traitements immunosuppresseurs co\u00fbteux utilis\u00e9s en rhumatologie et gastro-ent\u00e9rologie, y compris en p\u00e9diatrie. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 17 septembre, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 […]<\/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-17908","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\/17908","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=17908"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17908\/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=17908"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17908"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17908"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}