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).
周三，FDA接受了GSK plc（纽交所：GSK）的营销申请，旨在获得gepotidacin的批准，这是一种用于成年和青少年女性患有非复杂性尿路感染（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已为此申请授予了优先审查，并指定了2025年3月26日的处方药用户费法案（PDUFA）行动日期。
Also Read: GSK Sues Moderna Alleging mRNA Vaccine Patent Infringement.
也请查阅：GSK控告现代a侵犯mRNA疫苗专利权。
Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.
超过一半的女性在一生中会受到尿路感染的影响，大约30%患有反复发作性疾病。
New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.
随着由耐药细菌引起的尿路感染数量增加，新型治疗方法是必要的，并且可能导致更高的治疗失败率。
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不断增长的传染病产品组合中处于晚期的抗生素，可能成为20多年来针对uUTIs的新一类口服抗生素中的第一种。
The application is supported by data from phase 3 EAGLE-2 and EAGLE-3 trials.
该申请获得了EAGLE-2和EAGLE-3试验的数据支持。
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.
在这些研究中，gepotidacin证明了对nitrofurantoin的非劣效性，这是目前用于对具有对nitrofurantoin敏感的尿路感染进行治疗的标准。
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，吉波替达金相对硝基呋喃胺达到了统计学上的显著优势，治疗成功率为58.5%，而硝基呋喃胺为43.6%。
In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for nitrofurantoin.
在EAGLE-2中，吉波替达金显示出50.6%的参与者治疗成功率，而硝基呋喃胺为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).
吉波替达金的研发部分资金来自美国卫生及公众服务部战略防灾和应对管理局生物医药先进研究和发展局（BARDA）的联邦基金。
Price Action: GSK stock is up 0.40% at $39.12 at last check Wednesday.
股价走势：GSK股票在最后一次核查周三上涨了0.40%，报39.12美元。
Image via Shutterstock
图片来自shutterstock。
- Abbott Laboratories' Q3 Earnings: Revenue And EPS Beat, Company Says Well-Positioned To Achieve Upper End Of Annual Forecast.
- 雅培实验室第三季度财报：营收和每股收益超过预期，公司表示有望实现年度预测的上限。
