{"id":3684,"date":"2025-04-14T12:28:50","date_gmt":"2025-04-14T09:28:50","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3684"},"modified":"2025-06-21T13:47:29","modified_gmt":"2025-06-21T10:47:29","slug":"duvyzat-givinostat-ema-approval","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/duvyzat-givinostat-ema-approval\/","title":{"rendered":"Givinostat EMA Onay\u0131: Givinostat (Duvyzat) EMA Taraf\u0131ndan Onayland\u0131 m\u0131?"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Duvyzat (Givinostat), ABD ve \u0130ngiltere&#039;de d\u00fczenleyici onay ald\u0131 ve Avrupa \u0130la\u00e7 Ajans\u0131 (EMA) taraf\u0131ndan de\u011ferlendirmesini tamamlad\u0131. EMA, alt\u0131 ya\u015f\u0131ndan itibaren y\u00fcr\u00fcyebilen hastalarda Duchenne kas distrofisi (DMD) tedavisi i\u00e7in Duvyzat (givinostat) i\u00e7in Avrupa Birli\u011fi&#039;nde (AB) ko\u015fullu pazarlama yetkisi verilmesini \u00f6nerdi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Duchenne Musk\u00fcler Distrofi (DMD) i\u00e7in ilk steroid olmayan tedavi olan Duvyzat (givinostat), Mart 2024&#039;te FDA onay\u0131n\u0131 ald\u0131. Bu, t\u00fcm hastalar ve aileleri i\u00e7in iyi bir haber olsa da, Amerika Birle\u015fik Devletleri d\u0131\u015f\u0131ndaki bir\u00e7ok ki\u015fi, givinostat&#039;\u0131n DMD i\u00e7in kendi \u00fclkelerinde ne zaman onaylanaca\u011f\u0131n\u0131 merak ediyordu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Avrupa \u0130la\u00e7 Ajans\u0131 (EMA), Duvyzat&#039;ye (givinostat) alt\u0131 ya\u015f\u0131ndan itibaren y\u00fcr\u00fcyebilen bireylerde Duchenne kas distrofisi (DMD) tedavisi i\u00e7in AB&#039;de ko\u015fullu pazarlama yetkisi verilmesini \u00f6nerdi. Duvyzat, kortikosteroid tedavisiyle birlikte oral yoldan verilen bir s\u00fcspansiyondur.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#what-is-givinostat-used-for\">Givinostat ne i\u00e7in kullan\u0131l\u0131r?<\/a><\/li><li><a href=\"#how-does-givinostat-work\">Givinostat nas\u0131l \u00e7al\u0131\u015f\u0131r?<\/a><\/li><li><a href=\"#givinostat-ema-approval-status\">Givinostat EMA onay durumu<\/a><\/li><li><a href=\"#when-will-givinostat-be-available-in-europe\">Givinostat Avrupa&#039;da ne zaman sat\u0131\u015fa sunulacak?<\/a><\/li><li><a href=\"#italfarmaco-and-medis-announce-exclusive-distribution\">Givinostat Avrupa \u00fclkelerinde nas\u0131l da\u011f\u0131t\u0131lacak?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-givinostat-used-for\">Givinostat ne i\u00e7in kullan\u0131l\u0131r?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Alt\u0131 ya\u015f \u00fcst\u00fc Duchenne Musk\u00fcler Distrofi (DMD) hastalar\u0131 duvyzat (givinostat) ile tedavi edilebilir. \u0130lac\u0131n \u00fcreticisi Italfarmaco, givinostat&#039;\u0131n i\u015flev \u015fekli nedeniyle Becker musk\u00fcler distrofi (BMD) tedavisinde de kullan\u0131labilece\u011fini \u00f6ne s\u00fcrm\u00fc\u015ft\u00fcr. Bununla birlikte, ila\u00e7 hen\u00fcz BMD&#039;yi tedavi etmek i\u00e7in yetkilendirilmemi\u015ftir. (<a href=\"https:\/\/dmdwarrior.com\/tr\/duvyzat-givinostat-nonsteroidal-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duvyzat (Givinostat) Nedir?<\/a>)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"how-does-givinostat-work\">Givinostat nas\u0131l \u00e7al\u0131\u015f\u0131r?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Givinostat, HDAC&#039;nin bir inhibit\u00f6r\u00fcd\u00fcr. Histon deasetilazlar, inhibe etti\u011fi bir enzim s\u0131n\u0131f\u0131d\u0131r (HDAC&#039;ler). Duchenne&#039;de kas rejenerasyonunu potansiyel olarak azaltan genler, HDAC&#039;ler taraf\u0131ndan aktive edilir ve deaktive edilir. Givinostat, HDAC&#039;leri bloke ederek kas onar\u0131m\u0131n\u0131 te\u015fvik etmek, kas lifi rejenerasyonunu art\u0131rmak ve inflamasyonu ve fibrozu azaltmak i\u00e7in \u00e7al\u0131\u015f\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"givinostat-ema-approval-status\">Givinostat EMA onay durumu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CHMP, Duvyzat&#039;nin 25 Nisan 2025&#039;te Duchenne kas distrofisini tedavi etmek i\u00e7in AB taraf\u0131ndan onaylanmas\u0131n\u0131 \u00f6nerdi.<a href=\"https:\/\/dmdwarrior.com\/tr\/ema-recommends-eu-approval-for-duvyzat-givinostat-to-treat-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Devam\u0131n\u0131 oku<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Italfarmaco, 6 Haziran 2025 tarihinde Avrupa Komisyonu&#039;nun (EC) yeni histon deasetilaz (HDAC) inhibit\u00f6r\u00fc Duvyzat&#039;ye (givinostat) ko\u015fullu pazarlama izni verdi\u011fini duyurdu.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"when-will-givinostat-be-available-in-europe\">Givinostat Avrupa&#039;da ne zaman sat\u0131\u015fa sunulacak?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CHMP taraf\u0131ndan kabul edilen g\u00f6r\u00fc\u015f, Duvyzat&#039;nin hasta eri\u015fimi yolunda bir ara ad\u0131md\u0131r. G\u00f6r\u00fc\u015f \u015fimdi AB \u00e7ap\u0131nda bir pazarlama yetkisi hakk\u0131nda bir karar\u0131n kabul\u00fc i\u00e7in Avrupa Komisyonu&#039;na g\u00f6nderilecektir. Bir pazarlama yetkisi verildikten sonra, fiyat ve geri \u00f6demeyle ilgili kararlar, bu ilac\u0131n o \u00fclkenin ulusal sa\u011fl\u0131k sistemi ba\u011flam\u0131ndaki potansiyel rol\u00fc\/kullan\u0131m\u0131 dikkate al\u0131narak her \u00dcye Devlet d\u00fczeyinde ger\u00e7ekle\u015fecektir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"italfarmaco-and-medis-announce-exclusive-distribution\">Givinostat Avrupa \u00fclkelerinde nas\u0131l da\u011f\u0131t\u0131lacak?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Italfarmaco&#039;nun Duchenne kas distrofisi (DMD) ilac\u0131 olan Givinostat (Duvyzat), 18 Mart 2025&#039;te yay\u0131nlanan bir a\u00e7\u0131klamaya g\u00f6re, Orta ve Do\u011fu Avrupa&#039;n\u0131n \u00f6nde gelen ila\u00e7 ticarile\u015ftirme i\u015fletmelerinden biri olan Medis taraf\u0131ndan \u00f6zel olarak da\u011f\u0131t\u0131lacak.<a href=\"https:\/\/dmdwarrior.com\/tr\/italfarmaco-and-medis-distribution-agreement-for-givinostat-in-17-central-and-eastern-european-countries\/\">Devam\u0131n\u0131 oku<\/a>)<\/p>","protected":false},"excerpt":{"rendered":"<p>Duvyzat (Givinostat) has received regulatory approval in the US and UK and has completed its evaluation by the European Medicines Agency (EMA). EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3690,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[46,91,84,213,47],"class_list":["post-3684","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-duvyzat","tag-ema","tag-europe","tag-european-medicines-agency","tag-givinostat"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3684","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=3684"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3684\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3690"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3684"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}