{"id":7195,"date":"2025-03-25T09:44:47","date_gmt":"2025-03-25T09:44:47","guid":{"rendered":"https:\/\/hsderma.com\/?p=7195"},"modified":"2025-03-26T02:07:49","modified_gmt":"2025-03-26T02:07:49","slug":"bimzelx-dobio-fda-odobrenje","status":"publish","type":"post","link":"https:\/\/hsderma.com\/index.php\/2025\/03\/25\/bimzelx-dobio-fda-odobrenje\/","title":{"rendered":"\ud83d\ude80 BIMZELX\u00ae dobio FDA odobrenje!"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7195\" class=\"elementor elementor-7195\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6b81e0d3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6b81e0d3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7cd252a6\" data-id=\"7cd252a6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-58c4f820 elementor-widget elementor-widget-text-editor\" data-id=\"58c4f820\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3><strong>\ud83d\udcf0 UCB dobija odobrenje FDA za BIMZELX\u00ae (bimekizumab-bkzx) kao prvi inhibitor IL-17A i IL-17F za odrasle sa umerenim do te\u0161kim oblikom hidradenitis suppurative<\/strong><\/h3><hr \/><h3>\ud83c\udfe5 <strong>Novo odobrenje pru\u017ea nadu pacijentima sa hidradenitis suppurativom<\/strong><\/h3><p>Kompanija UCB je 20. novembra 2024. godine objavila da je ameri\u010dka Agencija za hranu i lekove (FDA) odobrila <strong>BIMZELX\u00ae (bimekizumab-bkzx)<\/strong> za le\u010denje odraslih pacijenata sa umerenim do te\u0161kim oblikom hidradenitis suppurative (HS). Ovo odobrenje \u010dini BIMZELX\u00ae prvim i jedinim lekom koji selektivno inhibira interleukine 17A (IL-17A) i 17F (IL-17F), klju\u010dne citokine uklju\u010dene u inflamatorne procese kod HS-a.<\/p><hr \/><h3>\ud83d\udd2c <strong>Klini\u010dka ispitivanja BE HEARD potvr\u0111uju efikasnost<\/strong><\/h3><p>Odobrenje se zasniva na podacima iz dve faze 3 klini\u010dkih ispitivanja, <strong>BE HEARD I<\/strong> i <strong>BE HEARD II<\/strong>, u kojima je bimekizumab-bkzx pokazao zna\u010dajno pobolj\u0161anje znakova i simptoma bolesti u pore\u0111enju sa placebom nakon 16 nedelja, a efekti su se odr\u017eali do 48. nedelje.<\/p><hr \/><h3>\ud83e\udd1d <strong>Zna\u010daj za zajednicu obolelih od HS-a<\/strong><\/h3><p>Brindley Brooks, osniva\u010d i izvr\u0161ni direktor organizacije <strong>HS Connect<\/strong>, izjavio je: &#8220;Radimo ka svetu u kojem ljudi sa hidradenitis suppurativom \u017eive bez stigme, ose\u0107aju se shva\u0107eno i imaju efikasno le\u010denje. Dana\u0161nje odobrenje bimekizumaba-bkzx je uzbudljiv trenutak za HS zajednicu, pru\u017eaju\u0107i novu mogu\u0107nost le\u010denja za ljude u SAD koji \u017eive sa umerenim do te\u0161kim oblikom bolesti.&#8221;<\/p><hr \/><h3>\ud83c\udf0d <strong>\u0160irenje indikacija za BIMZELX\u00ae<\/strong><\/h3><p>Ovo odobrenje predstavlja petu indikaciju za bimekizumab-bkzx u SAD, nakon prethodnih odobrenja za le\u010denje:<\/p><ul><li>Aktivnog psorijati\u010dnog artritisa.<\/li><li>Aktivne neradiografske aksijalne spondiloartritisa sa objektivnim znacima upale.<\/li><li>Aktivnog ankilozantnog spondilitisa.<\/li><\/ul><p>Ovo nagla\u0161ava posve\u0107enost kompanije UCB podizanju standarda nege u razli\u010ditim bolestima posredovanim IL-17.<\/p><hr \/><h3>\ud83d\udd17 <strong>Originalna vest:<\/strong><\/h3><p><a href=\"https:\/\/www.ucb.com\/newsroom\/press-releases\/article\/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa\" target=\"_new\" rel=\"noopener\">UCB dobija odobrenje FDA za BIMZELX\u00ae (bimekizumab-bkzx) kao prvi inhibitor IL-17A i IL-17F za odrasle sa umerenim do te\u0161kim oblikom hidradenitis suppurative<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p> Prvi IL-17A i IL-17F inhibitor donosi napredak u le\u010denju HS-a<\/p>\n","protected":false},"author":1,"featured_media":7197,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[31,30],"tags":[50,52,48,51,49],"class_list":["post-7195","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lekovi","category-vazno","tag-efikasnolecenjehs","tag-inovacijauzdravstvu","tag-novanadazahs","tag-podrskahszajednici","tag-prviil17inhibitor"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/posts\/7195","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/comments?post=7195"}],"version-history":[{"count":13,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/posts\/7195\/revisions"}],"predecessor-version":[{"id":8997,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/posts\/7195\/revisions\/8997"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/media\/7197"}],"wp:attachment":[{"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/media?parent=7195"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/categories?post=7195"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hsderma.com\/index.php\/wp-json\/wp\/v2\/tags?post=7195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}