URECE (dotinurad): n\u00fdr lyfjavalkostur vi\u00f0 \u00fevags\u00fdrugigt \u2014 hverju m\u00e1 b\u00faast vi\u00f0 \u00e1 \u00cdslandi?<\/p>\n
N\u00fdtt lyf me\u00f0 \u00feekkta verkun<\/strong><\/p>\n URECE er v\u00f6rumerki dotinurad, lyfs sem hindrar enduruppt\u00f6ku \u00fevags\u00fdru \u00ed n\u00fdrum me\u00f0 \u00fev\u00ed a\u00f0 hamla URAT1-flutningapr\u00f3teininu. \u00dea\u00f0 l\u00e6kkar \u00feannig \u00fevags\u00fdrugildi \u00ed bl\u00f3\u00f0i og telst til n\u00fdrri kynsl\u00f3\u00f0ar urikos\u00faric (urate-lowering) lyfja.<\/p>\n Hvar hefur \u00fea\u00f0 fengi\u00f0 sam\u00feykki og veri\u00f0 sett \u00e1 marka\u00f0?<\/strong><\/p>\n Dotinurad var fyrst sam\u00feykkt marka\u00f0sett \u00ed Japan (2020). S\u00ed\u00f0ar voru \u00fatgefin marka\u00f0sleyfi \u00ed nokkrum \u00f6\u00f0rum l\u00f6ndum, m.a. Thailand (2024) og K\u00edna (NMPA sam\u00feykkt desember 2024; formlega innlei\u00f0ing \u00e1 sumum m\u00f6rku\u00f0um h\u00f3fst 2025). Eisai\/Fuji hafa sta\u00f0fest sl\u00edkan \u00e1fanga \u00ed tilkynningum.<\/p>\n V\u00edsindalegur stu\u00f0ningur<\/strong><\/p>\n Fleiri ranns\u00f3kna-greinar og kl\u00edn\u00edskar ranns\u00f3knir fr\u00e1 Japan s\u00fdna a\u00f0 dotinurad l\u00e6kkar markt\u00e6kt serum-uric-gildi og var almennt vel \u00feola\u00f0 \u00ed \u00feeim h\u00f3pum sem rannsaka\u00f0ir voru. \u00ddmsar n\u00fdrri ranns\u00f3knir sko\u00f0a notkun vi\u00f0 sj\u00faklinga me\u00f0 n\u00fdrnarsj\u00fakd\u00f3m e\u00f0a \u00fe\u00e1 sem skortir sv\u00f6r vi\u00f0 hef\u00f0bundnum lyfjum.<\/p>\n Sta\u00f0a \u00ed Evr\u00f3pu \/ Bandar\u00edkjunum og m\u00f6guleg a\u00f0gengi \u00e1 \u00cdslandi<\/strong><\/p>\n R\u00e9tt n\u00fa (mi\u00f0a\u00f0 vi\u00f0 opinberar tilkynningar og skr\u00e1ningar) hefur dotinurad ekki fengi\u00f0 marka\u00f0sleyfi fr\u00e1 EMA e\u00f0a FDA. R\u00e9ttara er a\u00f0 segja a\u00f0 fj\u00f6ldi fyrirt\u00e6kja s\u00e6kjast eftir leyfi \u00ed \u00fer\u00f3un\/marka\u00f0sleyfisferli fyrir Nor\u00f0ur-Amer\u00edku og Evr\u00f3pu \u2014 t.d. samningar um \u00fer\u00f3un\/leyfi hj\u00e1 Fortress \/ Urica\/UR-1 sem stefna \u00e1 marka\u00f0i \u00ed Bandar\u00edkjunum, Bretlandi og ESB\/EEA. \u00deess vegna er lyfi\u00f0 ekki almennt f\u00e1anlegt \u00ed Evr\u00f3pu n\u00e9 \u00e1 \u00cdslandi nema \u00ed undantekningum (t.d. ranns\u00f3knar- e\u00f0a s\u00e9rleyfislei\u00f0um).<\/p>\n \u00cdsland er hluti af EEA og lyf sem hloti\u00f0 hafa mi\u00f0l\u00e6ga marka\u00f0sleyfi hj\u00e1 EMA eru venjulega a\u00f0gengileg h\u00e9r me\u00f0 tilv\u00edsun til EEA-reglna; ef dotinurad f\u00e6r s\u00ed\u00f0ar EMA-leyfi myndi bi\u00f0in ekki ver\u00f0a l\u00f6ng \u00feanga\u00f0 til a\u00f0 vi\u00f0 myndum sj\u00e1 marka\u00f0ssetningu og\u00a0 notkun fyrir \u00edslenskar heilsug\u00e6slur og heilbrig\u00f0isstofnanir fyrir sj\u00faklinga.<\/p>\n Kostna\u00f0ur og ni\u00f0urgrei\u00f0sla \u2014 hverju m\u00e1 b\u00faast vi\u00f0?<\/strong><\/p>\n N\u00e1kv\u00e6m ver\u00f0lagning fyrir Evr\u00f3pu e\u00f0a \u00cdsland er ekki opinber enn (ver\u00f0 sem sj\u00faklingar munu grei\u00f0a og samningavi\u00f0r\u00e6\u00f0ur um ni\u00f0urgrei\u00f0slu\/lyfjagjald muni r\u00e1\u00f0ast af framlei\u00f0anda og lyfjastofnunum). Sum \u00f3sta\u00f0fest tilbo\u00f0 og sm\u00e1um birg\u00f0askr\u00e1m \u00e1 netinu s\u00fdna ver\u00f0tilbo\u00f0, en \u00feau eru ekki traustar heimildir fyrir opinbert ver\u00f0. Fyrirhugsa\u00f0ur kostna\u00f0ur \u00ed framt\u00ed\u00f0inni ver\u00f0ur h\u00e1\u00f0ur: (a) marka\u00f0sleyfi, (b) hvort lyfi\u00f0 ver\u00f0i meti\u00f0 af \u00edslenskum grei\u00f0slumi\u00f0st\u00f6\u00f0vum\/tryggingakerfi (sj\u00fakratryggingar\/Heilsug\u00e1tt), og (c) hva\u00f0a samninga framlei\u00f0andi n\u00e6r vi\u00f0 opinbera a\u00f0ila. \u00dev\u00ed mi\u00f0ur eru engar traustar opinberar heimildir um \u00edslenskan e\u00f0a evr\u00f3pskan s\u00f6luver\u00f0punkt \u00e1 \u00feessu stigi.<\/p>\n Samanbur\u00f0ur vi\u00f0 \u00f6nnur lyf (stutt)<\/strong><\/p>\n Dotinurad (URECE) er uricosuric (\u00fatskiljandi me\u00f0 n\u00fdrum, URAT1-hemill). \u00dea\u00f0 er \u00fev\u00ed beinna skyld \u00fev\u00ed sem benzbromarone ger\u00f0i, en me\u00f0 h\u00f6nnun sem mi\u00f0ar a\u00f0 meiri s\u00e9rt\u00e6kni.<\/p>\n Hef\u00f0bundin XOR-hemlar (t.d. allopurinol, febuxostat) vinna me\u00f0 \u00f6\u00f0rum h\u00e6tti (hindra framlei\u00f0slu \u00fevags\u00fdru). Fyrir suma sj\u00faklinga (t.d. \u00feeir sem svara ekki XOI e\u00f0a hafa \u00f3\u00feol) getur uricosuric lyf veri\u00f0 valkostur. Ranns\u00f3knir benda til a\u00f0 dotinurad hafi g\u00f3\u00f0an \u00e1hrifar\u00edkt og \u00feolandi pr\u00f3f\u00edll \u00ed \u00feeim jap\u00f6nsku kl\u00edn\u00edsku ranns\u00f3knum sem ger\u00f0ar hafa veri\u00f0.<\/p>\n Hva\u00f0 \u00fe\u00fd\u00f0ir \u00feetta fyrir \u00edslenska sj\u00faklinga \u00ed stuttu m\u00e1li?<\/strong><\/p>\n Urece \/ dotinurad er skrefi n\u00e6r marka\u00f0ssetningu \u2014 \u00fea\u00f0 er n\u00fa \u00ed notkun \u00ed Japan, Thailand og K\u00edna og hefur veri\u00f0 \u00fer\u00f3a\u00f0 og meti\u00f0 \u00ed ranns\u00f3knum.<\/p>\n Enn vantar st\u00f3ran hluta reglulegrar heimildar (EMA\/FDA) til a\u00f0 gera \u00fea\u00f0 a\u00f0gengilegt \u00ed Evr\u00f3pu og \u00fear me\u00f0 \u00e1 \u00cdslandi; \u00fer\u00f3un og leyfisums\u00f3knir eru hins vegar \u00ed gangi hj\u00e1 leyfish\u00f6fum\/leyfis\u00feegum.<\/p>\n Ver\u00f0 og ni\u00f0urgrei\u00f0slur \u00e1 \u00cdslandi eru \u00f3vissar \u00fear til framlei\u00f0andi s\u00e6kir um og f\u00e6r vi\u00f0eigandi heimildir og innlei\u00f0ing fer fram \u00ed samr\u00e1\u00f0i vi\u00f0 Lyfjastofnun\/tryggingakerfi.<\/p>\n Heimildir:<\/p>\n Yfirl\u00fdsingar\/Eisai: URECE (dotinurad) launch\/approval \u00ed K\u00edna og \u00f6\u00f0rum l\u00f6ndum.<\/p>\n Kl\u00edn\u00edskar ranns\u00f3knir og yfirlitsgreinar um dotinurad (pubmed \/ PMC).<\/p>\n Leyfis- og leyfis\u00fer\u00f3unartilkynningar (Fortress \/ Urica \/ Ur-1) um marka\u00f0i \u00ed NA og Evr\u00f3pu.<\/p>\n","protected":false},"excerpt":{"rendered":" URECE (dotinurad): n\u00fdr lyfjavalkostur vi\u00f0 \u00fevags\u00fdrugigt \u2014 hverju m\u00e1 b\u00faast vi\u00f0 \u00e1 \u00cdslandi? N\u00fdtt lyf me\u00f0 \u00feekkta verkun URECE er v\u00f6rumerki dotinurad, lyfs sem hindrar … <\/p>\n","protected":false},"author":1,"featured_media":1700,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[174],"tags":[],"class_list":["post-1699","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-frettir"],"_links":{"self":[{"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/posts\/1699","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/spegillinn.is\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1699"}],"version-history":[{"count":3,"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/posts\/1699\/revisions"}],"predecessor-version":[{"id":1703,"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/posts\/1699\/revisions\/1703"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/spegillinn.is\/index.php?rest_route=\/wp\/v2\/media\/1700"}],"wp:attachment":[{"href":"https:\/\/spegillinn.is\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1699"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/spegillinn.is\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1699"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/spegillinn.is\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1699"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}