{"id":3919,"date":"2025-06-08T11:23:06","date_gmt":"2025-06-08T08:23:06","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3919"},"modified":"2025-06-21T13:46:21","modified_gmt":"2025-06-21T10:46:21","slug":"european-commission-approves-duvyzat-for-the-treatment-of-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/european-commission-approves-duvyzat-for-the-treatment-of-duchenne-muscular-dystrophy\/","title":{"rendered":"Avrupa Komisyonu, Duchenne Musk\u00fcler Distrofi Tedavisi \u0130\u00e7in Duvyzat'\u0131 Onaylad\u0131"},"content":{"rendered":"

Avrupa Komisyonu (EC), Italfarmaco'nun 6 Haziran'da duyurdu\u011fu \u00fczere yeni histon deasetilaz (HDAC) inhibit\u00f6r\u00fc Duvyzat'ye (givinostat) ko\u015fullu pazarlama yetkisi verdi. Kortikosteroidlerle birlikte kullan\u0131ld\u0131\u011f\u0131nda, altta yatan genetik mutasyondan ba\u011f\u0131ms\u0131z olarak 6 ya\u015f ve \u00fczeri ayakta tedavi g\u00f6ren hastalarda Duchenne kas distrofisini (DMD) tedavi etmek i\u00e7in yetkilendirilmi\u015ftir. (Duvyzat (Givinostat) nedir?<\/a>)<\/p>\n\n\n\n

AB Komisyonu karar\u0131, Avrupa \u0130la\u00e7 Ajans\u0131'n\u0131n (EMA) \u0130nsan Kullan\u0131m\u0131na Y\u00f6nelik T\u0131bbi \u00dcr\u00fcnler Komitesi'nin (CHMP) 25 Nisan 2025'te olumlu bir g\u00f6r\u00fc\u015f bildirmesinin ard\u0131ndan geldi (Devam\u0131n\u0131 oku<\/strong>: EMA, Duvyzat i\u00e7in AB Onay\u0131 \u00d6neriyor<\/a>). 27 AB \u00fcyesinin yan\u0131 s\u0131ra \u0130zlanda, Lihten\u015ftayn ve Norve\u00e7 onay kapsam\u0131ndad\u0131r. Italfarmaco, AB genelinde Duvyzat'ye h\u0131zl\u0131 eri\u015fim sa\u011flamak i\u00e7in art\u0131k ulusal yetkililer ve da\u011f\u0131t\u0131m ortaklar\u0131yla yak\u0131n bir \u015fekilde i\u015f birli\u011fi yapmaktad\u0131r.<\/p>\n\n\n\n

Daha fazla bilgi edin<\/strong>: Givinostat'\u0131n 17 Orta ve Do\u011fu Avrupa \u00dclkesinde \u00d6zel Da\u011f\u0131t\u0131m Anla\u015fmas\u0131<\/a><\/p>\n\n\n\n

Givinostat (Duvyzat) EMA Taraf\u0131ndan Onayl\u0131 m\u0131?<\/h2>\n\n\n\n
    \n
  • Art\u0131k AB'de onaylanan Duvyzat, Duchenne kas distrofisi (DMD) hastal\u0131\u011f\u0131n\u0131n ilerlemesini geciktirmek i\u00e7in \u00f6nemli bir tedavi se\u00e7ene\u011fi sunuyor<\/li>\n\n\n\n
  • Duvyzat, 6 ya\u015f ve \u00fczeri y\u00fcr\u00fcyebilen hastalarda DMD i\u00e7in oral yoldan uygulanan bir tedavidir<\/li>\n\n\n\n
  • Onay, ayakta tedavi g\u00f6ren hastalarda anlaml\u0131 tedavi yararlar\u0131 g\u00f6steren Faz 3 EPIDYS deneme verilerine dayanmaktad\u0131r<\/li>\n<\/ul>\n\n\n\n

    Duvyzat'ye AB'de Avrupa Komisyonu taraf\u0131ndan ko\u015fullu pazarlama yetkisi verildi. Italfarmaco, terap\u00f6tik etkinli\u011fini daha fazla do\u011frulamay\u0131 ve karakterize etmeyi ama\u00e7layan daha fazla klinik ara\u015ft\u0131rma y\u00fcr\u00fct\u00fcrken, onay Duvyzat'yi 6 ya\u015f ve \u00fczeri ayaktan DMD hastalar\u0131na a\u00e7\u0131yor.<\/p>\n\n\n\n

    Mart 2024'te ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA), Duvyzat'yi AB d\u0131\u015f\u0131ndaki 6 ya\u015f ve \u00fczeri DMD hastalar\u0131n\u0131n tedavisinde kullan\u0131lmak \u00fczere onaylad\u0131. \u0130ngiltere'de \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri D\u00fczenleme Ajans\u0131 (MHRA), Duvyzat'yi 6 ya\u015f ve \u00fczeri ayakta tedavi g\u00f6ren hastalar i\u00e7in onaylad\u0131 ve ayakta tedavi g\u00f6rmeyen hastalar i\u00e7in ko\u015fullu olarak onaylad\u0131.<\/p>","protected":false},"excerpt":{"rendered":"

    The European Commission (EC) has given conditional marketing authorization to the new histone deacetylase (HDAC) inhibitor Duvyzat (givinostat), Italfarmaco announced on 6th June. When used in conjunction with corticosteroids, it is authorized to treat Duchenne muscular dystrophy (DMD) in ambulatory patients aged 6 and up, irrespective of the underlying genetic mutation. (What is Duvyzat (Givinostat)) […]<\/p>\n","protected":false},"author":1,"featured_media":3920,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45],"tags":[46,372,47],"class_list":["post-3919","post","type-post","status-publish","format-standard","has-post-thumbnail","category-approved-therapies-for-duchenne-muscular-dystrophy","tag-duvyzat","tag-european-commission","tag-givinostat"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3919","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=3919"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3919\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3920"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3919"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3919"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3919"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}