[6-K] GSK plc American Current Report (Foreign Issuer)
GSK announced that the US FDA has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 years and older (weighing 鈮�45 kg), with a Prescription Drug User Fee Act action date set for December 2025. The submission is supported by the EAGLE-1 phase III trial published in The Lancet, where oral gepotidacin (two doses of 3,000 mg) achieved a 92.6% success rate at the urogenital site (187/202) versus 91.2% (186/204) for intramuscular ceftriaxone plus oral azithromycin, meeting non-inferiority. No failures from bacterial persistence were reported and no serious drug-related adverse events were observed; the most common adverse reactions were mild to moderate gastrointestinal events. Gepotidacin previously received US approval as Blujepa for uncomplicated urinary tract infection and its development was funded in part by BARDA and the US Department of Defense.
GSK ha annunciato che la FDA statunitense ha accettato per revisione prioritaria una domanda supplementare di nuovo farmaco per gepotidacin come trattamento orale della gonorrea urogenitale non complicata nei pazienti di et脿 pari o superiore a 12 anni (peso 鈮�45 kg), con data di decisione ai sensi del Prescription Drug User Fee Act fissata per dicembre 2025. La sottomissione 猫 supportata dallo studio di fase III EAGLE-1 pubblicato su The Lancet, in cui gepotidacin orale (due dosi da 3.000 mg) ha ottenuto un tasso di successo del 92,6% a livello urogenitale (187/202) rispetto al 91,2% (186/204) per ceftriaxone intramuscolare pi霉 azitromicina orale, soddisfacendo il criterio di non inferiorit脿. Non sono stati segnalati fallimenti dovuti a persistenza batterica n茅 eventi avversi gravi correlati al farmaco; le reazioni avverse pi霉 comuni sono state disturbi gastrointestinali da lievi a moderati. Gepotidacin aveva gi脿 ricevuto l'approvazione negli USA come Blujepa per la cistite non complicata e il suo sviluppo 猫 stato in parte finanziato da BARDA e dal Dipartimento della Difesa degli Stati Uniti.
GSK anunci贸 que la FDA de EE. UU. ha aceptado para revisi贸n prioritaria una solicitud complementaria de nuevo f谩rmaco para gepotidacina como tratamiento oral de la gonorrea urogenital no complicada en pacientes de 12 a帽os o m谩s (peso 鈮�45 kg), con fecha de resoluci贸n seg煤n la Prescription Drug User Fee Act fijada para diciembre de 2025. La presentaci贸n est谩 respaldada por el ensayo de fase III EAGLE-1 publicado en The Lancet, donde gepotidacina oral (dos dosis de 3.000 mg) alcanz贸 una tasa de 茅xito del 92,6% en el sitio urogenital (187/202) frente al 91,2% (186/204) para ceftriaxona intramuscular m谩s azitromicina oral, cumpliendo el criterio de no inferioridad. No se informaron fracasos por persistencia bacteriana ni se observaron eventos adversos graves relacionados con el f谩rmaco; las reacciones adversas m谩s frecuentes fueron trastornos gastrointestinales de leves a moderados. Gepotidacina ya hab铆a recibido la aprobaci贸n en EE. UU. como Blujepa para la infecci贸n urinaria no complicada y su desarrollo fue financiado en parte por BARDA y el Departamento de Defensa de EE. UU.
GSK電� 氙戈淡 FDA臧� 12靹� 鞚挫儊(觳挫 鈮�45 kg) 頇橃瀽鞚� 牍勲车鞛§劚 鞖旊秬 靹标赴 鞛勳鞐� 雽�頃� 瓴疥惮 旃橂鞝滊 gepotidacin鞚� 氤挫订 鞁犾暯項堦皜鞁犾箔鞚� 鞖办劆鞁偓 雽�靸侅溂搿� 靾橂澖頄堧嫟瓿� 氚滍憸頄堨溂氅�, Prescription Drug User Fee Act鞐� 霐半ジ 瓴办爼 旮绊暅鞚� 2025雲� 12鞗�鞙茧 鞝曧枅鞀惦媹雼�. 鞝滌稖 鞛愲鞐愲姅 The Lancet鞐� 氚滍憸霅� EAGLE-1 3靸� 鞁滍棙鞚� 韽暔霅橃柎 鞛堧姅雿�, 頃措嫻 鞐瓣惮鞐愳劀 瓴疥惮 gepotidacin(3,000 mg 2須� 韴棳)鞚� 鞖旊秬 靹标赴鞐愳劀 92.6%(187/202)鞚� 靹标车毳犾潉 旮半頄堦碃, 攴检湣欤检偓 ceftriaxone瓿� 瓴疥惮 azithromycin 氤戩毄鞚� 91.2%(186/204)搿� 牍勳棿霌膘劚鞚� 於╈”頄堨姷雼堧嫟. 氚曧厡毽晞 鞛旍〈鞐� 鞚橅暅 鞁ろ尐電� 氤搓碃霅橃 鞎婌晿瓿�, 鞎诫 甏�霠� 欷戨寑頃� 鞚挫儊氚橃潙霃� 甏�彀半悩歆� 鞎婌晿鞙茧┌ 臧�鞛� 頋旐暅 鞚挫儊氚橃潙鞚� 瓴诫弰鞐愳劀 欷戨摫霃勳潣 鞙勳灔甏�瓿� 歃濎儊鞚挫棃鞀惦媹雼�. Gepotidacin鞚� 鞚挫爠鞐� 牍勲车鞛§劚 鞖旊臧愳椉鞐� 雽�頃� Blujepa搿� 氙戈淡 鞀轨澑鞚� 氚涭晿瓿�, 臧滊皽鞚� 攵�攵勳爜鞙茧 BARDA 氚� 氙戈淡 甑癌攵�鞚� 鞛愱笀 歆�鞗愳潉 氚涭晿鞀惦媹雼�.
GSK a annonc茅 que la FDA am茅ricaine a accept茅 en examen prioritaire une demande d'autorisation compl茅mentaire pour le gepotidacin en traitement oral de la gonorrh茅e urog茅nitale non compliqu茅e chez les patients 芒g茅s de 12 ans et plus (pesant 鈮�45 kg), avec une date d'action au titre du Prescription Drug User Fee Act fix茅e pour d茅cembre 2025. Le dossier est 茅tay茅 par l'essai de phase III EAGLE鈥�1 publi茅 dans The Lancet, o霉 le gepotidacin oral (deux doses de 3 000 mg) a obtenu un taux de succ猫s de 92,6% au site urog茅nital (187/202) contre 91,2% (186/204) pour le ceftriaxone intramusculaire associ茅 脿 l'azithromycine orale, r茅pondant au crit猫re de non鈥慽nf茅riorit茅. Aucun 茅chec d没 脿 une persistance bact茅rienne ni 茅v茅nement ind茅sirable grave li茅 au m茅dicament n'a 茅t茅 rapport茅 ; les r茅actions ind茅sirables les plus fr茅quentes 茅taient des troubles gastro鈥慽ntestinaux l茅gers 脿 mod茅r茅s. Le gepotidacin avait d茅j脿 obtenu l'approbation aux 脡tats鈥慤nis sous le nom de Blujepa pour l'infection urinaire non compliqu茅e, et son d茅veloppement a 茅t茅 partiellement financ茅 par la BARDA et le D茅partement de la D茅fense des 脡tats鈥慤nis.
GSK gab bekannt, dass die US-FDA einen erg盲nzenden Zulassungsantrag f眉r gepotidacin zur oralen Behandlung der unkomplizierten urogenitalen Gonorrhoe bei Patienten ab 12 Jahren (Gewicht 鈮�45 kg) zur vorrangigen Pr眉fung angenommen hat, mit einem nach dem Prescription Drug User Fee Act festgelegten Entscheidungstermin im Dezember 2025. Die Einreichung wird durch die Phase鈥慖II鈥慡tudie EAGLE鈥�1 gest眉tzt, die in The Lancet ver枚ffentlicht wurde: Orales gepotidacin (zwei Gaben zu je 3.000 mg) erzielte eine Erfolgsrate von 92,6% an der urogenitalen Stelle (187/202) gegen眉ber 91,2% (186/204) f眉r intramuskul盲res Ceftriaxon plus orale Azithromycin und erf眉llte damit die Nichtunterlegenheitskriterien. Es wurden keine Ausf盲lle durch bakterielle Persistenz und keine schwerwiegenden arzneimittelbedingten unerw眉nschten Ereignisse beobachtet; die h盲ufigsten Nebenwirkungen waren leichte bis m盲脽ige gastrointestinale Beschwerden. Gepotidacin hatte zuvor in den USA die Zulassung als Blujepa f眉r unkomplizierte Harnwegsinfektionen erhalten, und seine Entwicklung wurde teilweise von BARDA und dem US-Verteidigungsministerium finanziert.
- FDA accepted for priority review of gepotidacin for oral treatment of uncomplicated urogenital gonorrhoea, with a PDUFA action date in December 2025
- EAGLE-1 phase III results showed non-inferiority: 92.6% success (187/202) for gepotidacin versus 91.2% (186/204) for comparator
- No failures from bacterial persistence at the urogenital site were reported in either treatment arm in EAGLE-1
- No serious drug-related adverse events observed in the EAGLE-1 trial; safety consistent with prior studies
- Gepotidacin already approved in the US as Blujepa for uncomplicated urinary tract infection (uUTI), representing a second major US indication filed
- Development funded in part by US federal agencies including BARDA and the Department of Defense (explicit agreements cited)
- EAGLE-1 demonstrated non-inferiority, not superiority, which may influence clinical positioning versus established regimens
- Most common adverse reactions were mild-to-moderate gastrointestinal events, noted in the trial safety profile
Insights
TL;DR: Priority review and positive phase III data make gepotidacin a material regulatory milestone for GSK.
The FDA's acceptance for priority review and assignment of a PDUFA action date in December 2025 represent clear regulatory progress that could accelerate market access if approval follows. The EAGLE-1 trial demonstrated non-inferiority with 92.6% success for gepotidacin versus 91.2% for the comparator, and reported no serious drug-related adverse events, which supports the submission's clinical rationale. The filing is the second major US indication for gepotidacin after the prior approval for uUTI, and federal funding from BARDA and the Department of Defense is explicitly noted in the filing.
TL;DR: FDA priority review and a published phase III study strengthen the submission, with a decision expected in December 2025.
The submission is underpinned by EAGLE-1 data published in The Lancet, showing non-inferiority and no microbiological persistence at the urogenital site in either arm, which addresses key regulatory efficacy and microbiology endpoints. Safety findings in the trial were consistent with prior studies and reported no serious drug-related adverse events, though mild-to-moderate gastrointestinal events were the most common reactions. The filing follows an earlier US approval for uUTI, and the priority review designation indicates the FDA views the application as addressing an unmet need for a WHO-listed priority pathogen.
GSK ha annunciato che la FDA statunitense ha accettato per revisione prioritaria una domanda supplementare di nuovo farmaco per gepotidacin come trattamento orale della gonorrea urogenitale non complicata nei pazienti di et脿 pari o superiore a 12 anni (peso 鈮�45 kg), con data di decisione ai sensi del Prescription Drug User Fee Act fissata per dicembre 2025. La sottomissione 猫 supportata dallo studio di fase III EAGLE-1 pubblicato su The Lancet, in cui gepotidacin orale (due dosi da 3.000 mg) ha ottenuto un tasso di successo del 92,6% a livello urogenitale (187/202) rispetto al 91,2% (186/204) per ceftriaxone intramuscolare pi霉 azitromicina orale, soddisfacendo il criterio di non inferiorit脿. Non sono stati segnalati fallimenti dovuti a persistenza batterica n茅 eventi avversi gravi correlati al farmaco; le reazioni avverse pi霉 comuni sono state disturbi gastrointestinali da lievi a moderati. Gepotidacin aveva gi脿 ricevuto l'approvazione negli USA come Blujepa per la cistite non complicata e il suo sviluppo 猫 stato in parte finanziato da BARDA e dal Dipartimento della Difesa degli Stati Uniti.
GSK anunci贸 que la FDA de EE. UU. ha aceptado para revisi贸n prioritaria una solicitud complementaria de nuevo f谩rmaco para gepotidacina como tratamiento oral de la gonorrea urogenital no complicada en pacientes de 12 a帽os o m谩s (peso 鈮�45 kg), con fecha de resoluci贸n seg煤n la Prescription Drug User Fee Act fijada para diciembre de 2025. La presentaci贸n est谩 respaldada por el ensayo de fase III EAGLE-1 publicado en The Lancet, donde gepotidacina oral (dos dosis de 3.000 mg) alcanz贸 una tasa de 茅xito del 92,6% en el sitio urogenital (187/202) frente al 91,2% (186/204) para ceftriaxona intramuscular m谩s azitromicina oral, cumpliendo el criterio de no inferioridad. No se informaron fracasos por persistencia bacteriana ni se observaron eventos adversos graves relacionados con el f谩rmaco; las reacciones adversas m谩s frecuentes fueron trastornos gastrointestinales de leves a moderados. Gepotidacina ya hab铆a recibido la aprobaci贸n en EE. UU. como Blujepa para la infecci贸n urinaria no complicada y su desarrollo fue financiado en parte por BARDA y el Departamento de Defensa de EE. UU.
GSK電� 氙戈淡 FDA臧� 12靹� 鞚挫儊(觳挫 鈮�45 kg) 頇橃瀽鞚� 牍勲车鞛§劚 鞖旊秬 靹标赴 鞛勳鞐� 雽�頃� 瓴疥惮 旃橂鞝滊 gepotidacin鞚� 氤挫订 鞁犾暯項堦皜鞁犾箔鞚� 鞖办劆鞁偓 雽�靸侅溂搿� 靾橂澖頄堧嫟瓿� 氚滍憸頄堨溂氅�, Prescription Drug User Fee Act鞐� 霐半ジ 瓴办爼 旮绊暅鞚� 2025雲� 12鞗�鞙茧 鞝曧枅鞀惦媹雼�. 鞝滌稖 鞛愲鞐愲姅 The Lancet鞐� 氚滍憸霅� EAGLE-1 3靸� 鞁滍棙鞚� 韽暔霅橃柎 鞛堧姅雿�, 頃措嫻 鞐瓣惮鞐愳劀 瓴疥惮 gepotidacin(3,000 mg 2須� 韴棳)鞚� 鞖旊秬 靹标赴鞐愳劀 92.6%(187/202)鞚� 靹标车毳犾潉 旮半頄堦碃, 攴检湣欤检偓 ceftriaxone瓿� 瓴疥惮 azithromycin 氤戩毄鞚� 91.2%(186/204)搿� 牍勳棿霌膘劚鞚� 於╈”頄堨姷雼堧嫟. 氚曧厡毽晞 鞛旍〈鞐� 鞚橅暅 鞁ろ尐電� 氤搓碃霅橃 鞎婌晿瓿�, 鞎诫 甏�霠� 欷戨寑頃� 鞚挫儊氚橃潙霃� 甏�彀半悩歆� 鞎婌晿鞙茧┌ 臧�鞛� 頋旐暅 鞚挫儊氚橃潙鞚� 瓴诫弰鞐愳劀 欷戨摫霃勳潣 鞙勳灔甏�瓿� 歃濎儊鞚挫棃鞀惦媹雼�. Gepotidacin鞚� 鞚挫爠鞐� 牍勲车鞛§劚 鞖旊臧愳椉鞐� 雽�頃� Blujepa搿� 氙戈淡 鞀轨澑鞚� 氚涭晿瓿�, 臧滊皽鞚� 攵�攵勳爜鞙茧 BARDA 氚� 氙戈淡 甑癌攵�鞚� 鞛愱笀 歆�鞗愳潉 氚涭晿鞀惦媹雼�.
GSK a annonc茅 que la FDA am茅ricaine a accept茅 en examen prioritaire une demande d'autorisation compl茅mentaire pour le gepotidacin en traitement oral de la gonorrh茅e urog茅nitale non compliqu茅e chez les patients 芒g茅s de 12 ans et plus (pesant 鈮�45 kg), avec une date d'action au titre du Prescription Drug User Fee Act fix茅e pour d茅cembre 2025. Le dossier est 茅tay茅 par l'essai de phase III EAGLE鈥�1 publi茅 dans The Lancet, o霉 le gepotidacin oral (deux doses de 3 000 mg) a obtenu un taux de succ猫s de 92,6% au site urog茅nital (187/202) contre 91,2% (186/204) pour le ceftriaxone intramusculaire associ茅 脿 l'azithromycine orale, r茅pondant au crit猫re de non鈥慽nf茅riorit茅. Aucun 茅chec d没 脿 une persistance bact茅rienne ni 茅v茅nement ind茅sirable grave li茅 au m茅dicament n'a 茅t茅 rapport茅 ; les r茅actions ind茅sirables les plus fr茅quentes 茅taient des troubles gastro鈥慽ntestinaux l茅gers 脿 mod茅r茅s. Le gepotidacin avait d茅j脿 obtenu l'approbation aux 脡tats鈥慤nis sous le nom de Blujepa pour l'infection urinaire non compliqu茅e, et son d茅veloppement a 茅t茅 partiellement financ茅 par la BARDA et le D茅partement de la D茅fense des 脡tats鈥慤nis.
GSK gab bekannt, dass die US-FDA einen erg盲nzenden Zulassungsantrag f眉r gepotidacin zur oralen Behandlung der unkomplizierten urogenitalen Gonorrhoe bei Patienten ab 12 Jahren (Gewicht 鈮�45 kg) zur vorrangigen Pr眉fung angenommen hat, mit einem nach dem Prescription Drug User Fee Act festgelegten Entscheidungstermin im Dezember 2025. Die Einreichung wird durch die Phase鈥慖II鈥慡tudie EAGLE鈥�1 gest眉tzt, die in The Lancet ver枚ffentlicht wurde: Orales gepotidacin (zwei Gaben zu je 3.000 mg) erzielte eine Erfolgsrate von 92,6% an der urogenitalen Stelle (187/202) gegen眉ber 91,2% (186/204) f眉r intramuskul盲res Ceftriaxon plus orale Azithromycin und erf眉llte damit die Nichtunterlegenheitskriterien. Es wurden keine Ausf盲lle durch bakterielle Persistenz und keine schwerwiegenden arzneimittelbedingten unerw眉nschten Ereignisse beobachtet; die h盲ufigsten Nebenwirkungen waren leichte bis m盲脽ige gastrointestinale Beschwerden. Gepotidacin hatte zuvor in den USA die Zulassung als Blujepa f眉r unkomplizierte Harnwegsinfektionen erhalten, und seine Entwicklung wurde teilweise von BARDA und dem US-Verteidigungsministerium finanziert.
FAQ
What did GSK (GSK) announce regarding gepotidacin?
How effective was gepotidacin in the EAGLE-1 phase III trial?
What safety results were reported for gepotidacin in EAGLE-1?
Has gepotidacin been approved for any indication in the US?
Who funded the development of gepotidacin?
