{"id":1241,"date":"2020-02-14T21:55:59","date_gmt":"2020-02-14T20:55:59","guid":{"rendered":"http:\/\/www.cisztasfibrozis.hu\/?p=1241"},"modified":"2020-04-23T23:21:53","modified_gmt":"2020-04-23T21:21:53","slug":"az-fda-elsobbsegi-elbiralast-biztosit-az-arv-1801","status":"publish","type":"post","link":"https:\/\/www.cisztasfibrozis.hu\/index.php\/2020\/02\/14\/az-fda-elsobbsegi-elbiralast-biztosit-az-arv-1801\/","title":{"rendered":"Az FDA els\u0151bbs\u00e9gi elb\u00edr\u00e1l\u00e1st biztos\u00edt az  &#8220;ARV-1801&#8221; tablett\u00e1nak, amely egy lehets\u00e9ges antibiotikumos k\u00fara CF betegek t\u00fcd\u0151gyullad\u00e1s fell\u00e1ngol\u00e1sa ellen"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">   Az <a href=\"https:\/\/arrevus.com\/\" target=\"_blank\" rel=\"noopener\">Arrevus<\/a> gy\u00f3gyszerfejleszt\u0151 c\u00e9g bejelentette, hogy az amerikai \u00c9lelmiszer- \u00e9s Gy\u00f3gyszer-enged\u00e9lyeztet\u00e9si Hivatal (Food and Drug Administration &#8211; FDA) els\u0151bbs\u00e9gi elb\u00edr\u00e1l\u00e1st biztos\u00edtott az <em>ARV-1801<\/em>  (n\u00e1trium-fuzid\u00e1t) tabletta sz\u00e1m\u00e1ra, amely egy lehets\u00e9ges t\u00fcd\u0151 exacerb\u00e1ci\u00f3 elleni,  sz\u00e1jon  \u00e1t t\u00f6rt\u00e9n\u0151 kezel\u00e9st  jelenthet  ciszt\u00e1s  fibr\u00f3zissal  kezelt betegek sz\u00e1m\u00e1ra.<\/h3>\n\n\n\n<p>   A c\u00e9g a sajt\u00f3k\u00f6zlem\u00e9nyben hozz\u00e1tette, hogy a betegeken v\u00e9gzett klinikai vizsg\u00e1lat is tervez\u00e9si f\u00e1zisban van.  <\/p>\n\n\n\n<p>   Az <em>ARV-1801<\/em> tabletta fert\u0151z\u00e9sek kezel\u00e9s\u00e9ben min\u0151s\u00edtett term\u00e9k (QIDP, qualified infectious   disease product) megjel\u00f6l\u00e9st kapott, amelyet azon antibakteri\u00e1lis szerek \u00e9rdemelhetnek ki, melyek a FDA krit\u00e9riumai szerint alkalmasak s\u00falyos vagy  \u00e9letet vesz\u00e9lyeztet\u0151 fert\u0151z\u00e9sek kezel\u00e9s\u00e9re. <\/p>\n\n\n\n<p>   A ciszt\u00e1s fibr\u00f3zis egyik velej\u00e1r\u00f3ja a t\u00fcd\u0151ben felhalmoz\u00f3dott s\u0171r\u0171 v\u00e1lad\u00e9k, amely kedvez\u0151 k\u00f6rnyezetet hozhat l\u00e9tre a bakt\u00e9riumoknak. A t\u00fcd\u0151 bakteri\u00e1lis fert\u0151z\u00e9sei gyakran vezetnek   pulmon\u00e1lis exacerb\u00e1ci\u00f3khoz, vagyis fell\u00e1ngol\u00e1sokhoz, amelyek k\u00f6vetkezt\u00e9ben akuttan romlik a t\u00fcd\u0151funkci\u00f3. Id\u0151vel a gyakori exacerb\u00e1ci\u00f3k tart\u00f3s t\u00fcd\u0151funkci\u00f3s roml\u00e1st okozhatnak a betegekn\u00e9l.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignleft is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/jnswire.s3.amazonaws.com\/jns-media\/9d\/97\/11380180\/ARV-1801.jpg\" alt=\"Pseudonomas bakt\u00e9rium elleni ujabb gy\u00f3gyszert enged\u00e9lyezhet az FDA\" width=\"306\" height=\"203\"\/><figcaption>Forr\u00e1s:  <a href=\"https:\/\/fdahealthnews.com\/\" target=\"_blank\" rel=\"noopener\">https:\/\/fdahealthnews.com\/<\/a> <\/figcaption><\/figure><\/div>\n\n\n\n<p>    A n\u00e1trium-fuzid\u00e1t az egyik leghat\u00e1sosabb antibiotikum a Staphylococcus Aureus bakt\u00e9rium ellen, amely hozz\u00e1vet\u0151legesen a t\u00fcd\u0151fert\u0151z\u00e9sek 70%-\u00e1t okozza a CF betegek eset\u00e9ben. Az antibiotikum a k\u00fcl\u00f6n\u00f6sen nehezen kezelhet\u0151 Meticillin-rezisztens Staphylococcus Aureus  (MRSA) ellen is hat\u00e1sos, valamint gyullad\u00e1scs\u00f6kkent\u0151 \u00e9s mukolitikus (k\u00f6pet\u00fcr\u00edt\u0151) hat\u00e1sa is van. <\/p>\n\n\n\n<p>    \u201eAz <em>ARV-1801<\/em> tabletta egyike azon kev\u00e9s sz\u00e1jon \u00e1t bevehet\u0151 antibiotikumnak, amelynek n\u00f6vekedett hat\u00e1sa van alacsony pH k\u00f6rnyezetben, illetve gyullad\u00e1scs\u00f6kkent\u0151 hat\u00e1ssal is b\u00edr. Mindkett\u0151 szempont kritikusan fontos egy olyan antibiotikumn\u00e1l, amely az exacerb\u00e1ci\u00f3s ciszt\u00e1s fibr\u00f3zisos betegek t\u00fcdej\u00e9t c\u00e9lozza meg.\u201d &#8211; nyilatkozta a sajt\u00f3t\u00e1j\u00e9koztat\u00f3n az Arrevus alap\u00edt\u00f3ja \u00e9s vez\u00e9rigazgat\u00f3ja, Carl N. Kraus. <\/p>\n\n\n\n<p>   A c\u00e9g jelent\u00e9se szerint jelenleg nincs specifikus kezel\u00e9si javaslat az USA-ban a pulmon\u00e1lis exacerb\u00e1ci\u00f3 kezel\u00e9s\u00e9re. <\/p>\n\n\n\n<p>   Az Arrevus \u2013 tervei szerint \u2013 klinikai vizsg\u00e1latot ind\u00edt a ciszt\u00e1s fibr\u00f3zisos betegek pulmon\u00e1lis fell\u00e1ngol\u00e1sainak <em>ARV-1801<\/em>-el val\u00f3 kezel\u00e9se c\u00e9lj\u00e1b\u00f3l, mivel a fejleszt\u00e9si program finansz\u00edroz\u00e1sa rendelkez\u00e9sre \u00e1ll. <\/p>\n\n\n\n<p>   Az  <em>ARV-1801<\/em> ki\u00e9rt\u00e9kel\u00e9s\u00e9re tervezett \u201esuperiority\u201d vizsg\u00e1lati hipot\u00e9zis a t\u00fcd\u0151 exacerb\u00e1ci\u00f3k (PEx) kezel\u00e9s\u00e9ben er\u0151s elk\u00f6telezetts\u00e9get jelent annak \u00e9rdek\u00e9ben, hogy a ciszt\u00e1s fibr\u00f3zisos betegek eredm\u00e9nyei javulhassanak  \u00e9s \u00e9n nagyon lelkesen t\u00e1mogatom ezeket az er\u0151fesz\u00edt\u00e9seket.\u201d- mondta Donald Van Devanter, a Case Western Reserve Orvosi Egyetem adjunktus professzora. Az Egyetem a <a href=\"http:\/\/www.cff.org\" target=\"_blank\" rel=\"noopener\">Cystic Fibrosis Foundation<\/a> (Ciszt\u00e1s Fibr\u00f3zis alap\u00edtv\u00e1ny) \u00e9s <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28457954\" target=\"_blank\" rel=\"noopener\">STOP<\/a> (Strandadized Treatment of Pulmonary Exacerbations &#8211; T\u00fcd\u0151  Exacerb\u00e1ci\u00f3k Strandardiz\u00e1lt Kezel\u00e9se) nev\u0171 kezdem\u00e9nyez\u00e9s tagja,valamint az Arrevus tan\u00e1csad\u00f3ja.  <\/p>\n\n\n\n<p class=\"has-background has-very-light-gray-background-color\">Ford\u00edtotta: <strong>Borb\u00edr\u00f3 Brigitta<\/strong><br>Forr\u00e1s: <a href=\"https:\/\/cysticfibrosisnewstoday.com\/author\/vanessa-pataia\/\" target=\"_blank\" rel=\"noopener\">Vanessa Pataia<\/a>: <a href=\"https:\/\/cysticfibrosisnewstoday.com\/2020\/01\/30\/arrevus-arv-1801-named-fda-qualified-infectious-disease-product-to-treat-pulmonary-flares-in-cf\" target=\"_blank\" rel=\"noopener\">Cystic Fibrosis News Today<\/a> 2020.01.30 <\/p>\n\n\n\n<figure class=\"wp-block-embed-wordpress wp-block-embed is-type-wp-embed is-provider-cystic-fibrosis-news-today\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"yoFdehVq0c\"><a href=\"https:\/\/cysticfibrosisnewstoday.com\/news\/arrevus-arv-1801-named-fda-qualified-infectious-disease-product-to-treat-pulmonary-flares-in-cf\/\" target=\"_blank\" rel=\"noopener\">FDA Grants Priority Review to ARV-1801, Potential Antibiotic for Pulmonary Flares in CF<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;FDA Grants Priority Review to ARV-1801, Potential Antibiotic for Pulmonary Flares in CF&#8221; &#8212; Cystic Fibrosis News Today\" src=\"https:\/\/cysticfibrosisnewstoday.com\/news\/arrevus-arv-1801-named-fda-qualified-infectious-disease-product-to-treat-pulmonary-flares-in-cf\/embed\/#?secret=XAw9oexuxt#?secret=yoFdehVq0c\" data-secret=\"yoFdehVq0c\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p>Kapcsol\u00f3d\u00f3 cikk:  <a href=\"http:\/\/www.cisztasfibrozis.hu\/index.php\/2020\/01\/29\/az_antibiotikumok_alternativai\/\">Az antibiotikumok alternat\u00edv\u00e1i <\/a><\/p>\n\n\n\n<p class=\"has-background has-very-light-gray-background-color\"><a href=\"http:\/\/www.cisztasfibrozis.hu\">Vissza a f\u0151oldalra<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Az Arrevus gy\u00f3gyszerfejleszt\u0151 c\u00e9g bejelentette, hogy az amerikai \u00c9lelmiszer- \u00e9s Gy\u00f3gyszer-enged\u00e9lyeztet\u00e9si Hivatal (Food and Drug Administration &#8211; FDA) els\u0151bbs\u00e9gi elb\u00edr\u00e1l\u00e1st biztos\u00edtott az ARV-1801 (n\u00e1trium-fuzid\u00e1t) tabletta&#8230;<\/p>\n","protected":false},"author":2,"featured_media":1253,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[57,66,67,33,65],"class_list":["post-1241","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","tag-antibiotikum","tag-arv-1801","tag-cff","tag-cisztas_fibrozis","tag-fda","entry","double"],"_links":{"self":[{"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/posts\/1241","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/comments?post=1241"}],"version-history":[{"count":25,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/posts\/1241\/revisions"}],"predecessor-version":[{"id":2124,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/posts\/1241\/revisions\/2124"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/media\/1253"}],"wp:attachment":[{"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/media?parent=1241"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/categories?post=1241"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cisztasfibrozis.hu\/index.php\/wp-json\/wp\/v2\/tags?post=1241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}