{"id":9915,"date":"2025-09-25T21:26:06","date_gmt":"2025-09-25T19:26:06","guid":{"rendered":"https:\/\/rvh-synergie.org\/actualites\/les-subventions-de-la-fda-ont-accelere-lapprobation-du-premier-traitement-du-syndrome-de-barth\/"},"modified":"2025-09-25T21:26:07","modified_gmt":"2025-09-25T19:26:07","slug":"les-subventions-de-la-fda-ont-accelere-lapprobation-du-premier-traitement-du-syndrome-de-barth","status":"publish","type":"post","link":"https:\/\/rvh-synergie.org\/actualites\/les-subventions-de-la-fda-ont-accelere-lapprobation-du-premier-traitement-du-syndrome-de-barth\/","title":{"rendered":"Les subventions de la FDA ont acc\u00e9l\u00e9r\u00e9 l&rsquo;approbation du premier traitement du syndrome de Barth"},"content":{"rendered":"<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2025\/fda-grants-accelerated.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/2025\/fda-grants-accelerated.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 accord\u00e9 une approbation acc\u00e9l\u00e9r\u00e9e \u00e0 l&rsquo;injection de forzinit\u00e9 (\u00e9lamipr\u00e9tide) comme premier traitement du syndrome de Barth.<\/p>\n<p>Le syndrome de Barth est une maladie rare, grave et potentiellement mortelle des mitochondries et de la forzine fonctionne en se liant \u00e0 la partie int\u00e9rieure des mitochondries, en am\u00e9liorant leur structure et leur fonction. Forzinity est administr\u00e9 par voie sous-cutan\u00e9e une fois par jour.<\/p>\n<p>L&rsquo;approbation est bas\u00e9e sur une am\u00e9lioration de la force du muscle utilis\u00e9 pour redresser la jambe au genou, ce qui est raisonnablement susceptible de pr\u00e9dire les b\u00e9n\u00e9fices des patients, comme une capacit\u00e9 \u00e0 se tenir plus facilement ou \u00e0 marcher plus loin. La FDA, en tant que condition d&rsquo;approbation acc\u00e9l\u00e9r\u00e9e, n\u00e9cessite un essai randomis\u00e9, en double aveugle et contr\u00f4l\u00e9 par placebo, pour confirmer que les changements observ\u00e9s dans la force du muscle du genou se traduisent par un b\u00e9n\u00e9fice du patient. Les effets secondaires les plus courants rapport\u00e9s dans les essais cliniques \u00e9taient des r\u00e9actions de sites d&rsquo;injection l\u00e9g\u00e8res \u00e0 mod\u00e9r\u00e9es, bien que des r\u00e9actions graves aient \u00e9galement \u00e9t\u00e9 rapport\u00e9es.<\/p>\n<p>\u00ab\u00a0La FDA reste d\u00e9termin\u00e9e \u00e0 faciliter le d\u00e9veloppement de th\u00e9rapies efficaces et s\u00fbres pour les maladies rares et continuera de travailler avec diligence pour aider les patients atteints de maladies rares ayant acc\u00e8s \u00e0 des traitements innovants\u00a0\u00bb, a d\u00e9clar\u00e9 George Tidmarsh, MD, Ph.D., directeur du Centre de la FDA pour l&rsquo;\u00e9valuation des m\u00e9dicaments et la recherche, dans un communiqu\u00e9.<\/p>\n<p>L&rsquo;approbation acc\u00e9l\u00e9r\u00e9e de Forzinity a \u00e9t\u00e9 accord\u00e9e aux bioth\u00e9rapeutiques furtifs.<\/p>\n<p>                                        <!-- print only --><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>La Food and Drug Administration des \u00c9tats-Unis a accord\u00e9 une approbation acc\u00e9l\u00e9r\u00e9e \u00e0 l&rsquo;injection de<\/p>\n","protected":false},"author":1,"featured_media":9916,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[86],"tags":[3310,6547,447,5070,49,66,322,4104,283,261],"class_list":["post-9915","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-les-maladies","tag-accelere","tag-barth","tag-fda","tag-lapprobation","tag-les","tag-ont","tag-premier","tag-subventions","tag-syndrome","tag-traitement","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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