{"id":3586,"date":"2025-04-08T15:29:57","date_gmt":"2025-04-08T12:29:57","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3586"},"modified":"2025-04-08T15:29:58","modified_gmt":"2025-04-08T12:29:58","slug":"new-drug-submission-for-agamree-vamorolone-accepted-for-priority-review-by-health-canada-for-the-treatment-of-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/de\/new-drug-submission-for-agamree-vamorolone-accepted-for-priority-review-by-health-canada-for-the-treatment-of-duchenne-muscular-dystrophy\/","title":{"rendered":"Health Canada hat den Zulassungsantrag f\u00fcr AGAMREE (Vamorolone) zur Behandlung der Duchenne-Muskeldystrophie zur vorrangigen Pr\u00fcfung angenommen"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Catalyst Pharmaceuticals hat bekannt gegeben, dass Health Canada den Zulassungsantrag (NDS) f\u00fcr AGAMREE (Vamorolone) zur Behandlung der Duchenne-Muskeldystrophie (DMD) mit vorrangigem Pr\u00fcfstatus angenommen hat. Im Falle einer Zulassung w\u00e4re AGAMREE die erste und einzige von Health Canada zugelassene Therapie f\u00fcr DMD mit einer m\u00f6glichen Marktzulassung bis Ende 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Der Antrag folgt auf die Zulassungen von AGAMREE in den USA (2023) und der Europ\u00e4ischen Union (Anfang 2024). Laut dem kanadischen Register f\u00fcr neuromuskul\u00e4re Erkrankungen leben in Kanada \u00fcber 800 Jungen und junge M\u00e4nner mit DMD, einer seltenen Krankheit, die aufgrund eines Mangels an Dystrophin-Protein zu Muskelschw\u00e4che f\u00fchrt. (<a href=\"https:\/\/dmdwarrior.com\/de\/what-is-agamree-vamorolone-what-is-agamree-used-for\/\" target=\"_blank\" data-type=\"post\" data-id=\"2333\" rel=\"noreferrer noopener\">Was ist Agamree?<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Die Entwicklung des Medikaments umfasste klinische Studien an f\u00fcnf kanadischen Standorten, die zu seiner weltweiten Zulassung beitrugen. Patientenorganisationen wie Defeat Duchenne Canada und Muscular Dystrophy Canada begr\u00fc\u00dften diese Entwicklung und wiesen auf den derzeitigen Mangel an zugelassenen Behandlungen in Kanada hin.<\/p>","protected":false},"excerpt":{"rendered":"<p>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&#8217;s approvals [&hellip;]<\/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"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/posts\/3586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/comments?post=3586"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/media\/3588"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/de\/wp-json\/wp\/v2\/tags?post=3586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}