{"id":882,"date":"2024-09-27T05:29:36","date_gmt":"2024-09-27T03:29:36","guid":{"rendered":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-locrevus-zunovo-injectable-pour-le-traitement-de-la-sclerose-en-plaques-recurrente-et-progressive\/"},"modified":"2024-09-27T05:29:38","modified_gmt":"2024-09-27T03:29:38","slug":"la-fda-approuve-locrevus-zunovo-injectable-pour-le-traitement-de-la-sclerose-en-plaques-recurrente-et-progressive","status":"publish","type":"post","link":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-locrevus-zunovo-injectable-pour-le-traitement-de-la-sclerose-en-plaques-recurrente-et-progressive\/","title":{"rendered":"La FDA approuve l&rsquo;Ocrevus Zunovo injectable pour le traitement de la scl\u00e9rose en plaques r\u00e9currente et progressive"},"content":{"rendered":"<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2024\/fda-approves-injectabl.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/2024\/fda-approves-injectabl.jpg\" data-sub-html=\"\">\n<figure class=\"article-img\">\n<\/figure><\/div>\n<\/div>\n<p>La Food and Drug Administration des \u00c9tats-Unis a approuv\u00e9 Ocrevus Zunovo (ocrelizumab et hyaluronidase-ocsq) comme premi\u00e8re et unique injection sous-cutan\u00e9e de 10 minutes deux fois par an pour les personnes atteintes de scl\u00e9rose en plaques (SEP) r\u00e9currente et progressive.<\/p>\n<p>L&rsquo;injection est administr\u00e9e par un professionnel de la sant\u00e9. Les patients re\u00e7oivent des pr\u00e9m\u00e9dications au moins 30 minutes avant chaque dose, puis sont surveill\u00e9s par leur prestataire de soins de sant\u00e9 pendant au moins 60 minutes apr\u00e8s l&rsquo;injection. Pour les doses ult\u00e9rieures, les patients seront surveill\u00e9s pendant au moins 15 minutes apr\u00e8s l&rsquo;injection.<\/p>\n<p>L&rsquo;approbation \u00e9tait bas\u00e9e sur les r\u00e9sultats de l&rsquo;essai de phase 3 OCARINA II, qui n&rsquo;ont montr\u00e9 aucune diff\u00e9rence cliniquement significative dans les taux d&rsquo;Ocrevus dans le sang lorsqu&rsquo;il est administr\u00e9 par voie sous-cutan\u00e9e ou intraveineuse. Le profil d&rsquo;innocuit\u00e9 et d&rsquo;efficacit\u00e9 \u00e9tait conforme \u00e0 celui de la formulation intraveineuse, Ocrevus d\u00e9montrant la suppression de l&rsquo;activit\u00e9 de rechute (97 %) et des l\u00e9sions d&rsquo;imagerie par r\u00e9sonance magn\u00e9tique (97 %) pendant 48 semaines. Concernant les r\u00e9sultats rapport\u00e9s par les patients, plus de 92\u00a0% des participants ont d\u00e9clar\u00e9 \u00eatre satisfaits ou tr\u00e8s satisfaits de l&rsquo;administration sous-cutan\u00e9e. Les \u00e9v\u00e9nements ind\u00e9sirables les plus fr\u00e9quemment observ\u00e9s avec Ocrevus \u00e9taient des r\u00e9actions \u00e0 l\u2019injection, 49\u00a0% des participants ayant pr\u00e9sent\u00e9 une r\u00e9action apr\u00e8s la premi\u00e8re injection. Toutes les r\u00e9actions \u00e9taient l\u00e9g\u00e8res ou mod\u00e9r\u00e9es, aucune n\u2019entra\u00eenant l\u2019arr\u00eat du traitement.<\/p>\n<p>\u00ab\u00a0Il est crucial de reconna\u00eetre que chaque exp\u00e9rience avec la SEP est aussi unique que la personne qui la vit, il est donc essentiel de proposer des choix pour r\u00e9pondre aux besoins de chaque personne\u00a0\u00bb, a d\u00e9clar\u00e9 Natalie Blake, directrice ex\u00e9cutive de la MS Foundation, dans un communiqu\u00e9. \u00ab\u00a0Nous sommes heureux qu&rsquo;avec une nouvelle m\u00e9thode d&rsquo;administration, il existe d\u00e9sormais une option suppl\u00e9mentaire pour ceux qui ont besoin de flexibilit\u00e9 dans la voie d&rsquo;administration ou la dur\u00e9e du traitement.\u00a0\u00bb<\/p>\n<p>L&rsquo;approbation d&rsquo;Ocrevus Zunovo a \u00e9t\u00e9 accord\u00e9e \u00e0 Genentech.<\/p>\n<p>                                        <!-- print only --><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>La Food and Drug Administration des \u00c9tats-Unis a approuv\u00e9 Ocrevus Zunovo (ocrelizumab et hyaluronidase-ocsq) comme<\/p>\n","protected":false},"author":1,"featured_media":883,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[86],"tags":[321,447,1127,1125,770,8,1128,970,769,261,1126],"class_list":["post-882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-les-maladies","tag-approuve","tag-fda","tag-injectable","tag-locrevus","tag-plaques","tag-pour","tag-progressive","tag-recurrente","tag-sclerose","tag-traitement","tag-zunovo","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","resize-featured-image"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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