{"id":16088,"date":"2016-09-26T07:18:40","date_gmt":"2016-09-26T05:18:40","guid":{"rendered":"http:\/\/mabdesign.fr\/sanofi-et-regeneron-annoncent-que-la-fda-a-accepte-lexamen-prioritaire-de-la-demande-de-licence-de-produit-biologique-pour-le-dupilumab\/"},"modified":"2016-09-26T07:18:40","modified_gmt":"2016-09-26T05:18:40","slug":"sanofi-et-regeneron-annoncent-que-la-fda-a-accepte-lexamen-prioritaire-de-la-demande-de-licence-de-produit-biologique-pour-le-dupilumab","status":"publish","type":"post","link":"https:\/\/mabdesign.fr\/en\/sanofi-et-regeneron-annoncent-que-la-fda-a-accepte-lexamen-prioritaire-de-la-demande-de-licence-de-produit-biologique-pour-le-dupilumab\/","title":{"rendered":"Sanofi et Regeneron annoncent que la FDA a accept\u00e9 l&#8217;examen prioritaire de la demande de licence de produit biologique pour le dupilumab"},"content":{"rendered":"<p style=\"text-align: justify;\"><strong>Sanofi <\/strong>\u00a0et Regeneron Pharmaceuticals, Inc. annoncent aujourd\u2019hui que la Food and Drug Administration (FDA) des \u00c9tats-Unis a accept\u00e9 d\u2019accorder un examen prioritaire \u00e0 la demande de licence de produit biologique (<em>Biologics License Application<\/em> ou BLA) pour le dupilumab dans le traitement de la dermatite atopique mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re inad\u00e9quatement contr\u00f4l\u00e9e de l\u2019adulte. La dermatite atopique est une maladie inflammatoire grave et chronique de la peau. En vertu des dispositions de la <em>Prescription Drug User Fee Act<\/em> (PDUFA, loi sur les frais de m\u00e9dicaments soumis \u00e0 prescription m\u00e9dicale), la FDA a fix\u00e9 au 29 mars 2017 la date de sa d\u00e9cision. Le traitement biologique exp\u00e9rimental dupilumab inhibe la signalisation d\u2019IL-4 et d\u2019IL-13, deux cytokines n\u00e9cessaires \u00e0 la r\u00e9ponse immunitaire de type 2 (y compris en Th2), l\u2019un des principaux facteurs de la pathogen\u00e8se de cette maladie.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><a href=\"http:\/\/mediaroom.sanofi.com\/sanofi-et-regeneron-annoncent-que-la-fda-des-etats-unis-a-accepte-lexamen-prioritaire-de-la-demande-de-licence-de-produit-biologique-pour-le-dupilumab%e2%80%8b\/\" target=\"_blank\" rel=\"noopener\">Lire le communiqu\u00e9 de presse<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sanofi  et Regeneron Pharmaceuticals, Inc. annoncent aujourd\u2019hui que la FDA a accept\u00e9 d\u2019accorder un examen prioritaire \u00e0 la demande de licence de produit biologique (BLA) pour le dupilumab dans le traitement de la dermatite atopique mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re inad\u00e9quatement contr\u00f4l\u00e9e de l\u2019adulte.<\/p>\n","protected":false},"author":1,"featured_media":8473,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,13],"tags":[],"class_list":["post-16088","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","category-nos-adherents"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Sanofi et Regeneron annoncent que la FDA a accept\u00e9 l&#039;examen prioritaire de la demande de licence de produit biologique pour le dupilumab - MabDesign<\/title>\n<meta name=\"description\" content=\"Sanofi et Regeneron Pharmaceuticals, Inc. annoncent aujourd\u2019hui que la FDA a accept\u00e9 d\u2019accorder un examen prioritaire \u00e0 la demande de licence de produit biologique (BLA) pour le dupilumab dans le traitement de la dermatite atopique 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