{"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\/tr\/new-drug-submission-for-agamree-vamorolone-accepted-for-priority-review-by-health-canada-for-the-treatment-of-duchenne-muscular-dystrophy\/","title":{"rendered":"AGAMREE (vamorolone) i\u00e7in Yeni \u0130la\u00e7 Ba\u015fvurusu, Duchenne Musk\u00fcler Distrofi Tedavisi \u0130\u00e7in Sa\u011fl\u0131k Kanada Taraf\u0131ndan \u00d6ncelikli \u0130nceleme \u0130\u00e7in Kabul Edildi"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Catalyst Pharmaceuticals, Sa\u011fl\u0131k Kanada&#039;n\u0131n Duchenne kas distrofisi (DMD) tedavisi i\u00e7in \u00f6ncelikli inceleme stat\u00fcs\u00fcyle AGAMREE (vamorolon) i\u00e7in Yeni \u0130la\u00e7 Ba\u015fvurusunu (NDS) kabul etti\u011fini duyurdu. Onaylan\u0131rsa, AGAMREE, 2025&#039;in sonuna kadar potansiyel pazarlama yetkisiyle DMD i\u00e7in Sa\u011fl\u0131k Kanada taraf\u0131ndan onaylanan ilk ve tek tedavi olacak.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ba\u015fvuru, AGAMREE&#039;nin ABD&#039;deki (2023) ve Avrupa Birli\u011fi&#039;ndeki (2024 ba\u015f\u0131) onaylar\u0131n\u0131 takip ediyor. Kanada N\u00f6rom\u00fcsk\u00fcler Hastal\u0131klar kay\u0131t defterine g\u00f6re, Kanada&#039;da 800&#039;den fazla erkek ve gen\u00e7 erkek, distrofin protein eksikli\u011finden kaynaklanan kas zay\u0131fl\u0131\u011f\u0131na neden olan nadir bir hastal\u0131k olan DMD ile ya\u015f\u0131yor. (<a href=\"https:\/\/dmdwarrior.com\/tr\/what-is-agamree-vamorolone-what-is-agamree-used-for\/\" target=\"_blank\" data-type=\"post\" data-id=\"2333\" rel=\"noreferrer noopener\">Agamree nedir?<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130lac\u0131n geli\u015ftirilmesi, k\u00fcresel onay\u0131na katk\u0131da bulunan be\u015f Kanada merkezinde klinik denemeleri i\u00e7eriyordu. Defeat Duchenne Canada ve Muscular Dystrophy Canada gibi hasta \u00f6rg\u00fctleri, Kanada&#039;da \u015fu anda onayl\u0131 tedavi eksikli\u011fini vurgulayarak bu geli\u015fmeyi memnuniyetle kar\u015f\u0131lad\u0131lar.<\/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"],"subtitle":"Kanada Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131, AGAMREE'ye \u00f6ncelikli inceleme izni verdi ve pazarlama izninin 2025 y\u0131l\u0131 sonundan \u00f6nce verilebilece\u011fi belirtildi.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=3586"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3588"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}