<p><img src="https://imageproxy.pbkrs.com/https://www.pharmexec.com/_next/image/query-cT03NSZ1cmw9aHR0cHM6Ly9jZG4uc2FuaXR5LmlvL2ltYWdlcy8wdnY4bW9jNi9waGFybWV4ZWMvODJiZDljMjVkYjhhYWNjOWFiZGQ4ZTIyZGIyZjZiMDQ0YjA2YjJlZC0xMjgweDcyMC5wbmc_Zml0PWNyb3AmYXV0bz1mb3JtYXQmdz0zODQw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmexec.com/_next/image/query-cT03NSZ1cmw9aHR0cHM6Ly9jZG4uc2FuaXR5LmlvL2ltYWdlcy8wdnY4bW9jNi9waGFybWV4ZWMvODJiZDljMjVkYjhhYWNjOWFiZGQ4ZTIyZGIyZjZiMDQ0YjA2YjJlZC0xMjgweDcyMC5wbmc_Zml0PWNyb3AmYXV0bz1mb3JtYXQmdz0zODQw"/></p>
<p><em>图片来源：Adobe Stock Images/Bungon</em></p>
<p><img src="https://imageproxy.pbkrs.com/https://cdn.sanity.io/images/0vv8moc6/pharmexec/82bd9c25db8aacc9abdd8e22db2f6b044b06b2ed-1280x720.png/query-YXV0bz1mb3JtYXQmZml0PWNyb3A?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://cdn.sanity.io/images/0vv8moc6/pharmexec/82bd9c25db8aacc9abdd8e22db2f6b044b06b2ed-1280x720.png/query-YXV0bz1mb3JtYXQmZml0PWNyb3A"/></p>
<p>美国 FDA 已批准葛兰素史克的 Blujepa（gepotidacin），这是一种用于治疗女性成人和 12 岁以上患者的非复杂性尿路感染（uUTIs）的首个口服抗生素。根据公司介绍，Blujepa 引入了一种新颖的作用机制，标志着近 30 年来首个用于 uUTIs 的新型口服抗生素。1</p>
<p>“Blujepa 的批准是一个重要的里程碑，因为 uUTIs 是女性中最常见的感染之一，” 葛兰素史克首席科学官 Tony Wood 在新闻稿中表示。“我们为开发 Blujepa 感到自豪，这是近三十年来首个用于 uUTIs 的新类口服抗生素，为面临复发感染和现有治疗耐药率上升的患者提供了另一种选择。”</p>
<p>批准是基于 III 期随机、多中心、双盲、双假药、非劣效性 EAGLE-2 和 EAGLE-3 试验的结果，这些试验评估了 Blujepa 的疗效和安全性。在试验中，EAGLE-2 的 1,531 名患者和 EAGLE-3 的 1,605 名患者以 1:1 的比例随机分配接受 Blujepa（剂量为每天两次 1,500 毫克）或硝呋太尔（剂量为每天两次 100 毫克）。研究的主要终点是在对硝呋太尔敏感的细菌患者中，治疗反应在治愈测试（第 10-13 天）时的表现。1,2</p>
<p>EAGLE-2 确认 Blujepa 的疗效不劣于硝呋太尔，接受 Blujepa 的患者中有 50.6% 取得了治疗成功，而硝呋太尔组为 47%。在 EAGLE-3 中，Blujepa 显示出统计学上的优越性，治疗成功率为 58.5%，而硝呋太尔组为 43.6%。</p>
<p>接受 Blujepa 治疗的患者中，最常见的不良事件（AEs）为胃肠道反应，包括腹泻和恶心。在所有胃肠道不良事件中，69% 为轻度，28% 为中度，3% 为重度。Blujepa 的安全性和耐受性特征与之前的临床试验一致。</p>
<p>根据葛兰素史克的数据，uUTIs 每年影响美国多达 1600 万女性，使其成为女性中最常见的细菌感染。全球范围内，超过 50% 的女性在其一生中会经历 uUTI，其中 30% 的人还会经历至少一次复发。</p>
<p>Blujepa 在美国的商业推出预计将在今年下半年进行。该项目的开发部分由美国卫生与公众服务部、战略准备与响应管理局、生物医学先进研究与发展局以及国防威胁减少局资助。1</p>
<p>根据_Medscape_的报道，20 至 40 岁女性中有 25% 至 40% 在其一生中至少经历过一次尿路感染。此外，尿路感染在过去一年内导致超过 600 万次就医，其中 20% 的病例是在急诊科报告的。女性的尿路感染发生率随着年龄的增长而增加。然而，18 至 30 岁的女性如果经历过蜜月膀胱炎或怀孕，更容易发展为尿路感染。在绝经后女性中，由于膀胱或子宫脱垂导致膀胱排空不完全，尿路感染的发生率往往增加。3</p>
<p>“对于许多人来说，uUTIs 可能是严重影响日常生活的负担，” 迈阿密大学医学院临床医学教授 Thomas Hooton 在新闻稿中表示。“随着越来越多的患者经历复发感染，持续研究抗微生物药物以帮助解决患者面临的挑战和医疗系统的压力仍然是明确的需求。”</p>
<p><strong>参考文献</strong></p>
<p>1. Blujepa（gepotidacin）获得美国 FDA 批准，用于治疗女性成人和 12 岁及以上儿童的非复杂性尿路感染（uUTIs）。_GSK._2025 年 3 月 25 日。访问日期：2025 年 3 月 26 日。https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/</p>
<p>2. 口服 gepotidacin 与硝呋太尔在非复杂性尿路感染患者中的比较（EAGLE-2 和 EAGLE-3）：两项随机、对照、双盲、双假药、III 期非劣效性试验。<em>ScienceDirect.</em> 访问日期：2025 年 3 月 26 日。https://www.sciencedirect.com/science/article/abs/pii/S0140673623021967#:~:text=EAGLE%2D2%20and%20EAGLE%2D3%20were%20phase%203%2C%20randomised%2C,patients%20were%20enrolled%20at%20219%20centres%20worldwide.&amp;text=The%20trials%20are%20registered%20with%20ClinicalTrials.gov%20%2C,(EAGLE%2D2)%20and%20NCT04187144%20(EAGLE%2D3)%2C%20and%20are%20completed.</p>
<p>3. 女性的尿路感染（UTI）和膀胱炎（膀胱感染）。<em>Medscape.</em> 访问日期：2025 年 3 月 26 日。https://emedicine.medscape.com/article/233101-overview#a5</p>

葛兰素史克

<p>美国食品药品监督管理局（FDA）已批准葛兰素史克的 Blujepa（gepotidacin），这是一种首创的口服抗生素，用于治疗女性和 12 岁以上患者的非复杂性尿路感染（uUTIs）。这标志着近 30 年来首个用于 uUTIs 的新型口服抗生素的问世。临床试验显示，Blujepa 的疗效显著，与硝呋太尔相比，其治疗成功率分别为 50.6% 和 58.5%。预计该药物将在今年下半年在美国商业上市，解决每年影响数百万女性的重大健康问题</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmexec.com/_next/image/query-cT03NSZ1cmw9aHR0cHM6Ly9jZG4uc2FuaXR5LmlvL2ltYWdlcy8wdnY4bW9jNi9waGFybWV4ZWMvODJiZDljMjVkYjhhYWNjOWFiZGQ4ZTIyZGIyZjZiMDQ0YjA2YjJlZC0xMjgweDcyMC5wbmc_Zml0PWNyb3AmYXV0bz1mb3JtYXQmdz0zODQw" alt="" original-src="https://www.pharmexec.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpharmexec%2F82bd9c25db8aacc9abdd8e22db2f6b044b06b2ed-1280x720.png%3Ffit%3Dcrop%26auto%3Dformat&amp;w=3840&amp;q=75"/></p>
<p><em>Image Credit: Adobe Stock Images/Bungon</em></p>
<div class="lb-trans"><p><em>图片来源：Adobe Stock Images/Bungon</em></p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cdn.sanity.io/images/0vv8moc6/pharmexec/82bd9c25db8aacc9abdd8e22db2f6b044b06b2ed-1280x720.png/query-YXV0bz1mb3JtYXQmZml0PWNyb3A" alt="" original-src="https://cdn.sanity.io/images/0vv8moc6/pharmexec/82bd9c25db8aacc9abdd8e22db2f6b044b06b2ed-1280x720.png?fit=crop&amp;auto=format"/></p>
<p>The FDA has approved GSK’s Blujepa (gepotidacin), a first-in-class oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and patients over 12 years of age. According to the company, Blujepa introduces a novel mechanism of action, marking the first new oral antibiotic for uUTIs in almost 30 years.1</p>
<div class="lb-trans"><p>美国 FDA 已批准葛兰素史克的 Blujepa（gepotidacin），这是一种用于治疗女性成人和 12 岁以上患者的非复杂性尿路感染（uUTIs）的首个口服抗生素。根据公司介绍，Blujepa 引入了一种新颖的作用机制，标志着近 30 年来首个用于 uUTIs 的新型口服抗生素。1</p>
</div><p>“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, chief scientific officer, GSK, in a press release. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”</p>
<div class="lb-trans"><p>“Blujepa 的批准是一个重要的里程碑，因为 uUTIs 是女性中最常见的感染之一，” 葛兰素史克首席科学官 Tony Wood 在新闻稿中表示。“我们为开发 Blujepa 感到自豪，这是近三十年来首个用于 uUTIs 的新类口服抗生素，为面临复发感染和现有治疗耐药率上升的患者提供了另一种选择。”</p>
</div><p>Approval was based on results from the Phase III randomized, multicenter, double-blind, double-dummy, non-inferiority EAGLE-2 and EAGLE-3 trials, which evaluated the efficacy and safety of Blujepa. In the trials, 1,531 patients in EAGLE-2 and 1,605 patients in EAGLE-3 were randomly assigned in a 1:1 ratio to receive either Blujepa at a dose of 1,500 mg twice daily or nitrofurantoin at a dose of 100 mg twice daily. The primary endpoint of the studies was therapeutic response at test-of-cure (day 10–13) in patients with bacteria susceptible to nitrofurantoin.1,2</p>
<div class="lb-trans"><p>批准是基于 III 期随机、多中心、双盲、双假药、非劣效性 EAGLE-2 和 EAGLE-3 试验的结果，这些试验评估了 Blujepa 的疗效和安全性。在试验中，EAGLE-2 的 1,531 名患者和 EAGLE-3 的 1,605 名患者以 1:1 的比例随机分配接受 Blujepa（剂量为每天两次 1,500 毫克）或硝呋太尔（剂量为每天两次 100 毫克）。研究的主要终点是在对硝呋太尔敏感的细菌患者中，治疗反应在治愈测试（第 10-13 天）时的表现。1,2</p>
</div><p>EAGLE-2 confirmed that Blujepa was non-inferior to nitrofurantoin, with therapeutic success in 50.6% of patients administered Blujepa compared to 47% in the nitrofurantoin group. In EAGLE-3, Blujepa demonstrated statistical superiority, achieving therapeutic success in 58.5% of patients compared to 43.6% in the nitrofurantoin group.</p>
<div class="lb-trans"><p>EAGLE-2 确认 Blujepa 的疗效不劣于硝呋太尔，接受 Blujepa 的患者中有 50.6% 取得了治疗成功，而硝呋太尔组为 47%。在 EAGLE-3 中，Blujepa 显示出统计学上的优越性，治疗成功率为 58.5%，而硝呋太尔组为 43.6%。</p>
</div><p>The most common adverse events (AEs) in patients treated with Blujepa were gastrointestinal, including diarrhea and nausea. Of all gastrointestinal AEs, 69% were mild, 28% were moderate, and 3% were severe. The safety and tolerability profile of Blujepa was consistent with previous clinical trials.</p>
<div class="lb-trans"><p>接受 Blujepa 治疗的患者中，最常见的不良事件（AEs）为胃肠道反应，包括腹泻和恶心。在所有胃肠道不良事件中，69% 为轻度，28% 为中度，3% 为重度。Blujepa 的安全性和耐受性特征与之前的临床试验一致。</p>
</div><p>According to GSK, uUTIs affect up to 16 million women in the United States annually, making them the most common bacterial infection in women. Globally, over 50% of women will experience a uUTI during their lifetime, 30% of whom will also experience at least one recurrence.</p>
<div class="lb-trans"><p>根据葛兰素史克的数据，uUTIs 每年影响美国多达 1600 万女性，使其成为女性中最常见的细菌感染。全球范围内，超过 50% 的女性在其一生中会经历 uUTI，其中 30% 的人还会经历至少一次复发。</p>
</div><p>The commercial launch of Blujepa in the United States is expected in the second half of this year. Development was partially funded by the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.1</p>
<div class="lb-trans"><p>Blujepa 在美国的商业推出预计将在今年下半年进行。该项目的开发部分由美国卫生与公众服务部、战略准备与响应管理局、生物医学先进研究与发展局以及国防威胁减少局资助。1</p>
</div><p>According to <em>Medscape</em>, 25% to 40% of women between 20 and 40 years of age have had at least one UTI during their lifetime. Additionally, UTIs have resulted in over six million visits to physician offices within the past year, with 20% of cases reported in emergency departments. The incidence of UTIs in women tends to increase with age. However, women between 18 and 30 years of age are more likely to develop a UTI if they have also experienced honeymoon cystitis or pregnancy. In postmenopausal women, the rates tend to increase due to bladder or uterine prolapse, which causes incomplete bladder emptying.3</p>
<div class="lb-trans"><p>根据_Medscape_的报道，20 至 40 岁女性中有 25% 至 40% 在其一生中至少经历过一次尿路感染。此外，尿路感染在过去一年内导致超过 600 万次就医，其中 20% 的病例是在急诊科报告的。女性的尿路感染发生率随着年龄的增长而增加。然而，18 至 30 岁的女性如果经历过蜜月膀胱炎或怀孕，更容易发展为尿路感染。在绝经后女性中，由于膀胱或子宫脱垂导致膀胱排空不完全，尿路感染的发生率往往增加。3</p>
</div><p>“For many, uUTIs can be a burden that severely impacts daily life,” said Thomas Hooton, MD, professor, clinical medicine, University of Miami School of Medicine, in the press release. “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.”</p>
<div class="lb-trans"><p>“对于许多人来说，uUTIs 可能是严重影响日常生活的负担，” 迈阿密大学医学院临床医学教授 Thomas Hooton 在新闻稿中表示。“随着越来越多的患者经历复发感染，持续研究抗微生物药物以帮助解决患者面临的挑战和医疗系统的压力仍然是明确的需求。”</p>
</div><p><strong>References</strong></p>
<div class="lb-trans"><p><strong>参考文献</strong></p>
</div><p>1. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. <em>GSK.</em> March 25, 2025. Accessed March 26, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/</p>
<div class="lb-trans"><p>1. Blujepa（gepotidacin）获得美国 FDA 批准，用于治疗女性成人和 12 岁及以上儿童的非复杂性尿路感染（uUTIs）。_GSK._2025 年 3 月 25 日。访问日期：2025 年 3 月 26 日。https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/</p>
</div><p>2. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. <em>ScienceDirect.</em> Accessed March 26, 2025. https://www.sciencedirect.com/science/article/abs/pii/S0140673623021967#:~:text=EAGLE%2D2%20and%20EAGLE%2D3%20were%20phase%203%2C%20randomised%2C,patients%20were%20enrolled%20at%20219%20centres%20worldwide.&amp;text=The%20trials%20are%20registered%20with%20ClinicalTrials.gov%20%2C,(EAGLE%2D2)%20and%20NCT04187144%20(EAGLE%2D3)%2C%20and%20are%20completed.</p>
<div class="lb-trans"><p>2. 口服 gepotidacin 与硝呋太尔在非复杂性尿路感染患者中的比较（EAGLE-2 和 EAGLE-3）：两项随机、对照、双盲、双假药、III 期非劣效性试验。<em>ScienceDirect.</em> 访问日期：2025 年 3 月 26 日。https://www.sciencedirect.com/science/article/abs/pii/S0140673623021967#:~:text=EAGLE%2D2%20and%20EAGLE%2D3%20were%20phase%203%2C%20randomised%2C,patients%20were%20enrolled%20at%20219%20centres%20worldwide.&amp;text=The%20trials%20are%20registered%20with%20ClinicalTrials.gov%20%2C,(EAGLE%2D2)%20and%20NCT04187144%20(EAGLE%2D3)%2C%20and%20are%20completed.</p>
</div><p>3. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females. <em>Medscape.</em> Accessed March 26, 2025. https://emedicine.medscape.com/article/233101-overview#a5</p>
<div class="lb-trans"><p>3. 女性的尿路感染（UTI）和膀胱炎（膀胱感染）。<em>Medscape.</em> 访问日期：2025 年 3 月 26 日。https://emedicine.medscape.com/article/233101-overview#a5</p>
</div>

FDA 批准了葛兰素史克的 Blujepa 用于治疗非复杂性尿路感染