{"id":4686,"date":"2025-10-02T15:50:03","date_gmt":"2025-10-02T12:50:03","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4686"},"modified":"2025-11-03T20:20:03","modified_gmt":"2025-11-03T17:20:03","slug":"health-canada-approves-agamree-vamorolone-as-the-first-treatment-for-duchenne-muscular-dystrophy-in-canada","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/fr\/health-canada-approves-agamree-vamorolone-as-the-first-treatment-for-duchenne-muscular-dystrophy-in-canada\/","title":{"rendered":"Sant\u00e9 Canada approuve AGAMREE (Vamorolone) comme premier traitement contre la dystrophie musculaire de Duchenne au Canada"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Kye Pharmaceuticals a annonc\u00e9 que Sant\u00e9 Canada a approuv\u00e9 AGAMREE (Vamorolone) pour le traitement de la dystrophie musculaire de Duchenne (DMD) chez les gar\u00e7ons de 4 ans et plus.<\/strong> Cette approbation, accord\u00e9e dans le cadre du processus d&#039;\u00e9valuation prioritaire de Sant\u00e9 Canada, marque une \u00e9tape importante\u00a0: AGAMREE devient le premier traitement approuv\u00e9 au Canada pour la DMD, une maladie d\u00e9g\u00e9n\u00e9rative musculaire qui touche principalement les jeunes gar\u00e7ons. \u2013 Lire la suite\u00a0: <a href=\"https:\/\/dmdwarrior.com\/fr\/what-is-agamree-vamorolone-what-is-agamree-used-for\/\" target=\"_blank\" data-type=\"post\" data-id=\"2333\" rel=\"noreferrer noopener\">Qu&#039;est-ce qu&#039;Agamree<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00ab Compte tenu des importants besoins non satisfaits des personnes atteintes de DMD, je suis ravie qu&#039;AGAMREE ait re\u00e7u une \u00e9valuation prioritaire et soit maintenant approuv\u00e9 par Sant\u00e9 Canada. Comme AGAMREE n&#039;a aucun effet sur la croissance lin\u00e9aire et a montr\u00e9 des changements favorables dans les biomarqueurs s\u00e9riques du remodelage osseux, il offre aux familles une option th\u00e9rapeutique viable comparativement aux autres corticost\u00e9ro\u00efdes \u00bb, d\u00e9clare la Dre Jean Mah, directrice du programme neuromusculaire p\u00e9diatrique de l&#039;Alberta Children&#039;s Hospital de Calgary.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;approbation d&#039;AGAMREE par Sant\u00e9 Canada s&#039;appuie sur les donn\u00e9es de l&#039;\u00e9tude pivot de phase IIb VISION-DMD, compl\u00e9t\u00e9es par des donn\u00e9es d&#039;innocuit\u00e9 recueillies lors de quatre \u00e9tudes ouvertes, dont des \u00e9tudes de prolongation. Dans ces essais, AGAMREE a \u00e9t\u00e9 administr\u00e9 \u00e0 des doses allant de 2 \u00e0 6 mg\/kg\/jour, sur une p\u00e9riode allant jusqu&#039;\u00e0 48 mois. Comparativement aux corticost\u00e9ro\u00efdes de r\u00e9f\u00e9rence actuels, ce nouveau traitement corticost\u00e9ro\u00efdien a d\u00e9montr\u00e9 une efficacit\u00e9 comparable, les donn\u00e9es sugg\u00e9rant une r\u00e9duction des effets ind\u00e9sirables, notamment li\u00e9s \u00e0 la sant\u00e9 osseuse, \u00e0 la trajectoire de croissance et au comportement.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Dans quels pays AGAMREE (Vamorolone) est-il approuv\u00e9\u00a0?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>AGAMREE est approuv\u00e9 aux \u00c9tats-Unis, dans l&#039;UE, au Royaume-Uni et en Chine.<\/strong> AGAMREE a \u00e9t\u00e9 conc\u00e9d\u00e9 sous licence par Santhera Pharmaceuticals \u00e0 Catalyst Pharmaceuticals, Inc. pour l&#039;Am\u00e9rique du Nord. En juillet 2024, Kye Pharmaceuticals a conclu un accord de sous-licence avec Catalyst pour la commercialisation d&#039;AGAMREE au Canada.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>En savoir plus<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/fr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Essais cliniques sur la dystrophie musculaire de Duchenne (Liste de toutes les recherches)<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Kye Pharmaceuticals announced that Health Canada has approved AGAMREE (vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD) in boys age 4 and older. This approval \u2013 granted under Health Canada\u2019s Priority Review process \u2013 marks an important milestone making AGAMREE the first treatment in Canada approved for DMD a muscle wasting disease that affects [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4687,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[42,171,43],"class_list":["post-4686","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-agamree","tag-canada","tag-vamorolone"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4686","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/comments?post=4686"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/4686\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/4687"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=4686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=4686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=4686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}