{"id":40093,"date":"2026-10-21T10:07:04","date_gmt":"2026-10-21T08:07:04","guid":{"rendered":"https:\/\/ggba.swiss\/legacy-healthcares-botanical-treatment-receives-fda-breakthrough-therapy-designation\/"},"modified":"2026-10-21T10:13:31","modified_gmt":"2026-10-21T08:13:31","slug":"le-traitement-botanique-de-legacy-healthcare-recoit-la-designation-breakthrough-therapy-de-la-fda","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/fr\/le-traitement-botanique-de-legacy-healthcare-recoit-la-designation-breakthrough-therapy-de-la-fda\/","title":{"rendered":"Le traitement botanique de Legacy Healthcare re\u00e7oit la d\u00e9signation Breakthrough Therapy de la FDA"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/legacyhealthcare.ch\/\">Legacy Healthcare<\/a>, qui d\u00e9veloppe des m\u00e9dicaments botaniques sur ordonnance et dispose de bureaux au Biop\u00f4le \u00e0 Lausanne, en France, aux \u00c9tats-Unis et au Japon, a annonc\u00e9 le 13 octobre 2026 que la <a href=\"https:\/\/www.fda.gov\/\">Food and Drug Administration<\/a> (FDA) am\u00e9ricaine a accord\u00e9 la d\u00e9signation Breakthrough Therapy \u00e0 Cinainu (LH-8). Cette solution topique exp\u00e9rimentale vise la pelade (alopecia areata) mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re, une forme auto-immune de perte de cheveux, chez les adultes, les adolescents et les enfants d\u00e8s l&rsquo;\u00e2ge de deux ans. La d\u00e9signation vise \u00e0 acc\u00e9l\u00e9rer le d\u00e9veloppement et l&rsquo;examen des th\u00e9rapies qui pr\u00e9sentent des preuves pr\u00e9liminaires d&rsquo;am\u00e9lioration substantielle par rapport aux traitements existants. Elle ne signifie pas que le m\u00e9dicament est approuv\u00e9. Selon l&rsquo;entreprise, Cinainu est le premier m\u00e9dicament botanique multiplantes r\u00e9glement\u00e9 par la FDA \u00e0 l&rsquo;obtenir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Les r\u00e9sultats de l&rsquo;essai RAAINBOW<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">La d\u00e9signation s&rsquo;appuie sur RAAINBOW, un essai international de phase 2\/3 en double aveugle contr\u00f4l\u00e9 par placebo, men\u00e9 aupr\u00e8s de 107 patients de 2 \u00e0 17 ans, randomis\u00e9s 2:1 entre Cinainu et placebo. Le traitement a dur\u00e9 24 semaines, suivies de 24 semaines sans traitement, et les r\u00e9sultats ont \u00e9t\u00e9 publi\u00e9s dans le British Journal of Dermatology. \u00c0 la semaine 24, 26,2% des patients trait\u00e9s par Cinainu avaient atteint une am\u00e9lioration d&rsquo;au moins 40% de leur score SALT, qui mesure la perte de cheveux du cuir chevelu, contre 5,0% sous placebo. L&rsquo;\u00e9cart entre les groupes \u00e9tait plus marqu\u00e9 \u00e0 la semaine 48, apr\u00e8s l&rsquo;arr\u00eat du traitement. Aucun \u00e9v\u00e9nement ind\u00e9sirable grave n&rsquo;a \u00e9t\u00e9 li\u00e9 \u00e0 Cinainu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cinainu associe quatre extraits botaniques aux effets anti-inflammatoires, antiapoptotiques et antioxydants suppos\u00e9s. L&rsquo;entreprise y voit une possible option de premi\u00e8re intention contre la pelade mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re et, sous r\u00e9serve d&rsquo;\u00e9tudes compl\u00e9mentaires, un traitement d&rsquo;entretien apr\u00e8s les inhibiteurs de JAK oraux, seuls traitements approuv\u00e9s de la maladie aujourd&rsquo;hui.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Vers une phase 3 mondiale<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Legacy Healthcare pr\u00e9pare un programme pivot de phase 3. RAAINBOW-2 est pr\u00e9vu comme un vaste essai multir\u00e9gional en double aveugle contr\u00f4l\u00e9 par placebo, portant sur au moins 500 patients, destin\u00e9 \u00e0 soutenir une future demande d&rsquo;autorisation de mise sur le march\u00e9 (NDA). Il a re\u00e7u l&rsquo;autorisation IND de la FDA, et la PMDA japonaise a accept\u00e9 la conduite de l&rsquo;essai mondial, qui inclut des patients japonais adultes et p\u00e9diatriques d\u00e8s l&rsquo;\u00e2ge de deux ans. Saad Harti, CEO de Legacy Healthcare, qualifie la d\u00e9cision de la FDA de \u00ab jalon majeur pour Cinainu&nbsp;\u00bb.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Legacy Healthcare, a obtenu de la FDA am\u00e9ricaine la d\u00e9signation Breakthrough Therapy pour Cinainu, un m\u00e9dicament botanique topique contre la pelade mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re chez les patients d\u00e8s l&rsquo;\u00e2ge de deux ans.<\/p>\n","protected":false},"author":6,"featured_media":40090,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[843],"tags":[1188,1142,1168],"class_list":["post-40093","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sciences-de-la-vie","tag-healthcare-fr-2","tag-rd-fr-2","tag-technology-park-fr-2"],"acf":[],"yoast_head":"<!-- This site is optimized 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