Catalyst Pharmaceuticals a annonc\u00e9 que Sant\u00e9 Canada a accept\u00e9 sa pr\u00e9sentation de drogue nouvelle (PDN) pour AGAMREE (vamorolone) avec un statut d'\u00e9valuation prioritaire pour le traitement de la dystrophie musculaire de Duchenne (DMD). S'il est approuv\u00e9, AGAMREE deviendrait le premier et le seul traitement approuv\u00e9 par Sant\u00e9 Canada pour la DMD, avec une autorisation de mise en march\u00e9 potentielle d'ici la fin de 2025.<\/p>\n\n\n\n
Cette demande fait suite aux approbations d'AGAMREE aux \u00c9tats-Unis (2023) et dans l'Union europ\u00e9enne (d\u00e9but 2024). Selon le Registre canadien des maladies neuromusculaires, plus de 800 gar\u00e7ons et jeunes hommes au Canada sont atteints de DMD, une maladie rare provoquant une faiblesse musculaire due \u00e0 un d\u00e9ficit en dystrophine.Qu'est-ce qu'Agamree ?<\/a>)<\/p>\n\n\n\n Le d\u00e9veloppement du m\u00e9dicament a inclus des essais cliniques dans cinq centres canadiens, contribuant ainsi \u00e0 son approbation mondiale. Des associations de patients, dont Vaincre la maladie de Duchenne Canada et Dystrophie musculaire Canada, ont salu\u00e9 cette avanc\u00e9e, soulignant le manque actuel de traitements approuv\u00e9s au Canada.<\/p>","protected":false},"excerpt":{"rendered":" Catalyst Pharmaceuticals has announced that Health Canada has accepted their New Drug Submission (NDS) for AGAMREE (vamorolone) with priority review status for treating Duchenne muscular dystrophy (DMD). If approved, AGAMREE would become the first and only Health Canada-approved therapy for DMD, with potential marketing authorization by the end of 2025. The submission follows AGAMREE’s approvals […]<\/p>\n","protected":false},"author":1,"featured_media":3588,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[42,171,43],"class_list":["post-3586","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-agamree","tag-canada","tag-vamorolone"],"subtitle":"Sant\u00e9 Canada a accord\u00e9 \u00e0 AGAMREE un examen prioritaire et l\u2019autorisation de mise sur le march\u00e9 pourrait \u00eatre accord\u00e9e avant la fin de 2025.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/3586","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=3586"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/3588"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=3586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}