GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.On Wednesday, the FDA accepted GSK plc's (NYSE:GSK) marketing application seeking approval for gepotidacin, an investigational, oral antibiotic for adult and adolescent females with uncomplicated urinary tract infections (uUTIs).
週三，FDA接受了GSK plc（紐交所：GSK）的營銷申請，旨在獲得gepotidacin的批准，這是一種用於成年和青少年女性患有非複雜性尿路感染（uUTI）的研究中口服抗生素。
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 26, 2025.
FDA已爲此申請授予了優先審查，並指定了2025年3月26日的處方藥用戶費法案（PDUFA）行動日期。
Also Read: GSK Sues Moderna Alleging mRNA Vaccine Patent Infringement.
也請查閱：GSK控告現代a侵犯mRNA疫苗專利權。
Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.
超過一半的女性在一生中會受到尿路感染的影響，大約30%患有反覆發作性疾病。
New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.
隨着由耐藥細菌引起的尿路感染數量增加，新型治療方法是必要的，並且可能導致更高的治療失敗率。
Gepotidacin is a late-stage antibiotic in GSK's growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years.
gepotidacin是GSK不斷增長的傳染病產品組合中處於晚期的抗生素，可能成爲20多年來針對uUTIs的新一類口服抗生素中的第一種。
The application is supported by data from phase 3 EAGLE-2 and EAGLE-3 trials.
該申請獲得了EAGLE-2和EAGLE-3試驗的數據支持。
In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin.
在這些研究中，gepotidacin證明了對nitrofurantoin的非劣效性，這是目前用於對具有對nitrofurantoin敏感的尿路感染進行治療的標準。
In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% of participants compared to 43.6% for nitrofurantoin.
在EAGLE-3中，吉波替達金相對硝基呋喃胺達到了統計學上的顯著優勢，治療成功率爲58.5%，而硝基呋喃胺爲43.6%。
In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for nitrofurantoin.
在EAGLE-2中，吉波替達金顯示出50.6%的參與者治療成功率，而硝基呋喃胺爲47.0%。
The development of gepotidacin has been partially funded by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
吉波替達金的研發部分資金來自美國衛生及公衆服務部戰略防災和應對管理局生物醫藥先進研究和發展局（BARDA）的聯邦基金。
Price Action: GSK stock is up 0.40% at $39.12 at last check Wednesday.
股價走勢：GSK股票在最後一次覈查週三上漲了0.40%，報39.12美元。
Image via Shutterstock
圖片來自shutterstock。
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