{"id":621,"date":"2026-02-10T14:49:33","date_gmt":"2026-02-10T06:49:33","guid":{"rendered":"https:\/\/www.pnf-ingredients.com\/?p=621"},"modified":"2026-02-10T14:49:34","modified_gmt":"2026-02-10T06:49:34","slug":"die-neuartigen-gepotidacin-tabletten-von-gsk-haben-die-fda-zulassung-fur-eine-neue-indikation-erhalten","status":"publish","type":"post","link":"https:\/\/www.pnf-ingredients.com\/de\/die-neuartigen-gepotidacin-tabletten-von-gsk-haben-die-fda-zulassung-fur-eine-neue-indikation-erhalten\/","title":{"rendered":"Das neuartige Antibiotikum Gepotidacin-Tabletten von GSK hat die FDA-Zulassung f\u00fcr eine neue Indikation erhalten."},"content":{"rendered":"<p>Laut Meldungen aus London hat das Pharmaunternehmen GlaxoSmithKline (GSK) bekannt gegeben, dass die US-amerikanische Arzneimittelbeh\u00f6rde FDA den erg\u00e4nzenden Zulassungsantrag f\u00fcr das neue orale Antibiotikum Gepotidacin (750 mg Tabletten, Handelsname: \u201cBlujepa\u201d) genehmigt hat. Dieses orale Medikament ist indiziert zur Behandlung unkomplizierter Gonorrh\u00f6 der Harnr\u00f6hre und der Genitalien, verursacht durch empfindliche Neisseria gonorrhoeae, bei Erwachsenen und Kindern ab 12 Jahren mit einem Gewicht von mindestens 45 kg, f\u00fcr die nur wenige oder keine anderen Behandlungsm\u00f6glichkeiten bestehen.<\/p>\n\n\n\n<p>Laut Meldungen aus London hat das Pharmaunternehmen GlaxoSmithKline (GSK) bekannt gegeben, dass die US-amerikanische Arzneimittelbeh\u00f6rde FDA den erg\u00e4nzenden Zulassungsantrag f\u00fcr das neue orale Antibiotikum Gepotidacin (750 mg Tabletten, Handelsname: \u201cBlujepa\u201d) genehmigt hat. Die orale Behandlung ist indiziert zur Behandlung unkomplizierter Gonorrh\u00f6 im Harnr\u00f6hren- und Genitalbereich, verursacht durch empfindliche Neisseria gonorrhoeae, bei Erwachsenen und Kindern ab 12 Jahren mit einem Gewicht von mindestens 45 kg, f\u00fcr die nur begrenzte oder keine anderen Behandlungsm\u00f6glichkeiten bestehen.<\/p>\n\n\n\n<p>Wissenschaftler von GSK entdeckten, dass Gepotidacin ein neuartiges bakterizides Antibiotikum der Triaza-Naphthyridin-Klasse ist, das die bakterielle DNA-Replikation \u00fcber eine einzigartige Bindungsstelle hemmt und einen neuartigen Wirkmechanismus aufweist. Es hemmt zwei verschiedene Topoisomerasen vom Typ II gegen die meisten Krankheitserreger in ausgewogenem Ma\u00dfe. Das Produkt ist wirksam gegen Neisseria gonorrhoeae und die meisten Harnwegserreger (wie Escherichia coli und Streptococcus pyogenes), einschlie\u00dflich St\u00e4mmen, die gegen g\u00e4ngige Antibiotika resistent sind. Aufgrund der guten, ausgewogenen antibakteriellen Wirkung von Gepotidacin gegen die meisten Krankheitserreger d\u00fcrften spezifische Mutationen an einem einzelnen Zielmolek\u00fcl seine Wirksamkeit nicht wesentlich beeintr\u00e4chtigen. Dar\u00fcber hinaus zielt das antimikrobielle Spektrum von Gepotidacin prim\u00e4r auf Bakterien vom Typ Escherichia coli ab. Dies bedeutet, dass sein Potenzial zur Induktion von Bakterienresistenzen im Vergleich zu Breitbandantibiotika geringer ist. GSK erwartet, dass Gepotidacin zuk\u00fcnftig einen j\u00e4hrlichen Spitzenumsatz von bis zu 2 Milliarden Pfund (ca. 1,4 bis 2,6 Milliarden Pfund) erzielen k\u00f6nnte.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u200cAccording to news reports from London, UK, pharmaceutical company GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for the novel oral antibiotic 750mg Gepotidacin tablets (brand name: &#8220;Blujepa&#8221;). This oral treatment is indicated for uncomplicated urethral and genital gonorrhea caused by susceptible Neisseria gonorrhoeae in [&hellip;]<\/p>","protected":false},"author":2,"featured_media":557,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6,4],"tags":[],"class_list":["post-621","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>GSK&#039;s novel antibiotic, Gepotidacin tablets, has received FDA approval for a new indication - PNF<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pnf-ingredients.com\/de\/die-neuartigen-gepotidacin-tabletten-von-gsk-haben-die-fda-zulassung-fur-eine-neue-indikation-erhalten\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GSK&#039;s novel antibiotic, Gepotidacin tablets, has received FDA approval for a new indication - PNF\" \/>\n<meta property=\"og:description\" content=\"\u200cAccording to news reports from London, UK, pharmaceutical company GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for the novel oral antibiotic 750mg Gepotidacin tablets (brand name: &#8220;Blujepa&#8221;). 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