{"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\/tr\/health-canada-approves-agamree-vamorolone-as-the-first-treatment-for-duchenne-muscular-dystrophy-in-canada\/","title":{"rendered":"Kanada Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131, Kanada'da Duchenne Musk\u00fcler Distrofisi i\u00e7in \u0130lk Tedavi Olarak AGAMREE'yi (Vamorolone) Onaylad\u0131"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Kye Pharmaceuticals, Sa\u011fl\u0131k Kanada'n\u0131n AGAMREE'yi (Vamorolone) 4 ya\u015f ve \u00fczeri erkek \u00e7ocuklar\u0131nda Duchenne Musk\u00fcler Distrofi (DMD) tedavisi i\u00e7in onaylad\u0131\u011f\u0131n\u0131 duyurdu.<\/strong> Kanada Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131&#039;n\u0131n \u00d6ncelikli \u0130nceleme s\u00fcreci kapsam\u0131nda verilen bu onay, AGAMREE&#039;nin, a\u011f\u0131rl\u0131kl\u0131 olarak gen\u00e7 erkek \u00e7ocuklar\u0131n\u0131 etkileyen bir kas erimesi hastal\u0131\u011f\u0131 olan DMD i\u00e7in Kanada&#039;da onaylanan ilk tedavi olmas\u0131n\u0131 sa\u011flayan \u00f6nemli bir d\u00f6n\u00fcm noktas\u0131n\u0131 temsil ediyor. \u2013 Devam\u0131n\u0131 Oku: <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> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">DMD&#039;li bireylerin kar\u015f\u0131lanmam\u0131\u015f \u00f6nemli ihtiya\u00e7lar\u0131 g\u00f6z \u00f6n\u00fcne al\u0131nd\u0131\u011f\u0131nda, AGAMREE&#039;nin \u00f6ncelikli incelemeden ge\u00e7mesinden ve art\u0131k Kanada Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan onaylanmas\u0131ndan memnuniyet duyuyorum. Calgary&#039;deki Alberta \u00c7ocuk Hastanesi Pediatrik N\u00f6rom\u00fcsk\u00fcler Program Direkt\u00f6r\u00fc Dr. Jean Mah, &quot;AGAMREE&#039;nin do\u011frusal b\u00fcy\u00fcme \u00fczerinde hi\u00e7bir etkisi olmad\u0131\u011f\u0131 ve serum kemik d\u00f6ng\u00fcs\u00fc biyobelirte\u00e7lerinde olumlu de\u011fi\u015fiklikler g\u00f6sterdi\u011fi i\u00e7in, ailelere di\u011fer kortikosteroidlere k\u0131yasla uygulanabilir bir tedavi se\u00e7ene\u011fi sunuyor&quot; diyor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AGAMREE&#039;nin Kanada Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan onaylanmas\u0131, uzatma \u00e7al\u0131\u015fmalar\u0131 da dahil olmak \u00fczere d\u00f6rt a\u00e7\u0131k etiketli \u00e7al\u0131\u015fmadan toplanan g\u00fcvenlik bilgileriyle desteklenen, temel Faz 2b VISION-DMD \u00e7al\u0131\u015fmas\u0131ndan elde edilen verilere dayanmaktad\u0131r. Bu \u00e7al\u0131\u015fmalarda, AGAMREE 2 ila 6 mg\/kg\/g\u00fcn dozlar\u0131nda uygulanm\u0131\u015f ve 48 aya kadar uzat\u0131lm\u0131\u015ft\u0131r. Mevcut standart tedavi kortikosteroidleriyle kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131\u011f\u0131nda, bu yeni kortikosteroid tedavisi benzer bir etkinlik g\u00f6stermi\u015f ve veriler, \u00f6zellikle kemik sa\u011fl\u0131\u011f\u0131, b\u00fcy\u00fcme e\u011filimi ve davran\u0131\u015fla ilgili yan etkilerde azalma oldu\u011funu g\u00f6stermi\u015ftir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">AGAMREE (Vamorolone) Hangi \u00dclkelerde Onayl\u0131d\u0131r?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>AGAMREE ABD, AB, \u0130ngiltere ve \u00c7in&#039;de onayl\u0131d\u0131r.<\/strong> AGAMREE, Kuzey Amerika i\u00e7in Santhera Pharmaceuticals&#039;dan Catalyst Pharmaceuticals, Inc.&#039;e lisanslanm\u0131\u015ft\u0131r. Temmuz 2024&#039;te Kye Pharmaceuticals, AGAMREE&#039;nin Kanada&#039;da ticarile\u015ftirilmesi haklar\u0131n\u0131 Catalyst&#039;ten alt lisanslama anla\u015fmas\u0131 imzalam\u0131\u015ft\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Devam\u0131n\u0131 oku<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/tr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duchenne \u0130\u00e7in Klinik Ara\u015ft\u0131rmalar (T\u00fcm Ara\u015ft\u0131rmalar\u0131n Listesi)<\/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\/tr\/wp-json\/wp\/v2\/posts\/4686","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=4686"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4686\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4687"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}