{"id":7338,"date":"2015-03-19T06:34:36","date_gmt":"2015-03-19T06:34:36","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-la-fda-accorde-au-naproxcinod-la-designation-de-medicament-orphelin-pour-la-dystrophie-musculaire-de-duchenne\/"},"modified":"2015-03-19T06:34:36","modified_gmt":"2015-03-19T06:34:36","slug":"nicox-la-fda-accorde-au-naproxcinod-la-designation-de-medicament-orphelin-pour-la-dystrophie-musculaire-de-duchenne","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-la-fda-accorde-au-naproxcinod-la-designation-de-medicament-orphelin-pour-la-dystrophie-musculaire-de-duchenne\/","title":{"rendered":"Nicox : la FDA accorde au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin pour la Dystrophie Musculaire de Duchenne"},"content":{"rendered":"<p>Sophia Antipolis, France<\/p>\n<p><strong>Nicox S.A<\/strong>. (Euronext Paris: COX) annonce aujourd\u2019hui que la <em>Food and Drug Administration<\/em> (FDA) am\u00e9ricaine a accord\u00e9 au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin (<em>Orphan Drug Designation,<\/em> ODD) pour le traitement de la Dystrophie Musculaire de Duchenne (DMD). La d\u00e9signation de m\u00e9dicament orphelin est attribu\u00e9e aux m\u00e9dicaments ou produits biologiques pour le traitement de maladies ou troubles rares. Cette d\u00e9signation permet au promoteur du m\u00e9dicament de b\u00e9n\u00e9ficier de plusieurs mesures d\u2019encouragement au d\u00e9veloppement, dont une p\u00e9riode d\u2019exclusivit\u00e9 commerciale aux Etats-Unis apr\u00e8s l\u2019autorisation de mise sur le march\u00e9 pour l\u2019indication concern\u00e9e, d\u2019\u00e9ventuels cr\u00e9dits d\u2019imp\u00f4t et l\u2019exon\u00e9ration de certaines taxes r\u00e9glementaires<sup><em>1<\/em><\/sup>.<\/p>\n<p>Le naproxcinod appartient \u00e0 la classe des anti-inflammatoires CINODs (Inhibiteurs de Cyclooxyg\u00e9nase Donneurs d\u2019Oxyde Nitrique). Une \u00e9valuation est actuellement conduite par un partenaire financier non divulgu\u00e9 en vue d\u2019un \u00e9ventuel d\u00e9veloppement clinique ult\u00e9rieur dans la DMD<sup><em>2<\/em><\/sup>. Nicox a allou\u00e9 au partenaire non divulgu\u00e9 le droit exclusif, en dehors de l\u2019ophtalmologie, d\u2019investir \u00e0 l\u2019issue de la p\u00e9riode d\u2019\u00e9valuation dans le naproxcinod et les NO-donneurs de nouvelle g\u00e9n\u00e9ration au travers d\u2019une structure ind\u00e9pendante, et ce sous r\u00e9serve que les r\u00e9sultats de l\u2019\u00e9valuation lui soient satisfaisants.<\/p>\n<p>La DMD est la forme la plus courante et la plus grave des dystrophies musculaires, un groupe de maladies h\u00e9r\u00e9ditaires qui provoquent une faiblesse et une d\u00e9g\u00e9n\u00e9rescence des muscles. Le naproxcinod a d\u00e9j\u00e0 obtenu des r\u00e9sultats pr\u00e9cliniques prometteurs dans des mod\u00e8les de dystrophies musculaires<sup>3<\/sup> et a re\u00e7u la d\u00e9signation de m\u00e9dicament orphelin en Europe en octobre 2013 pour le traitement de la DMD. <br \/>\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.<br \/>R\u00e9f\u00e9rences<br \/>1. Pour plus d\u2019informations, veuillez consulter le site internet de la FDA (en anglais) : <a href=\"http:\/\/www.fda.gov\/ForIndustry\/DevelopingProductsforRareDiseasesConditions\/default.htm.\">http:\/\/www.fda.gov\/ForIndustry\/DevelopingProductsforRareDiseasesConditions\/default.htm.<\/a><br \/>2. Voir communiqu\u00e9 de presse Nicox du 14 f\u00e9vrier 2014.<br \/>3. Long-term treatment with naproxcinod significantly improves skeletal and cardiac disease phenotype in the mdx mouse model of dystrophy, Uaesoontrachoon K, Quinn JL, Tatem KS, Van der Meulen JH, Yu Q, Phadke A, Miller BK, Gordish-Dressman H, Ongini E, Miglietta D, Nagaraju K. Hum Mol Genet. 2014, 15; 23(12):3239-49.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophia Antipolis, France Nicox S.A. (Euronext Paris: COX) annonce aujourd\u2019hui que la Food and Drug Administration (FDA) am\u00e9ricaine a accord\u00e9 au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin (Orphan Drug Designation, ODD) pour le traitement de la Dystrophie Musculaire de Duchenne (DMD). La d\u00e9signation de m\u00e9dicament orphelin est attribu\u00e9e aux m\u00e9dicaments ou produits biologiques pour le [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[32,16],"tags":[],"class_list":["post-7338","post","type-post","status-publish","format-standard","hentry","category-actualites","category-actualites-et-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nicox : la FDA accorde au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin pour la Dystrophie Musculaire de Duchenne - Nicox<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.nicox.com\/fr\/nicox-la-fda-accorde-au-naproxcinod-la-designation-de-medicament-orphelin-pour-la-dystrophie-musculaire-de-duchenne\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nicox : la FDA accorde au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin pour la Dystrophie Musculaire de Duchenne - Nicox\" \/>\n<meta property=\"og:description\" content=\"Sophia Antipolis, France Nicox S.A. (Euronext Paris: COX) annonce aujourd\u2019hui que la Food and Drug Administration (FDA) am\u00e9ricaine a accord\u00e9 au naproxcinod la d\u00e9signation de m\u00e9dicament orphelin (Orphan Drug Designation, ODD) pour le traitement de la Dystrophie Musculaire de Duchenne (DMD). 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