<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>圖片來源：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>美國 FDA 已批准葛蘭素史克的 Blujepa（gepotidacin），這是一種用於治療女性成人和 12 歲以上患者的非複雜性尿路感染（uUTIs）的首個口服抗生素。根據公司介紹，Blujepa 引入了一種新穎的作用機制，標誌着近 30 年來首個用於 uUTIs 的新型口服抗生素。1</p>
<p>“Blujepa 的批准是一個重要的里程碑，因為 uUTIs 是女性中最常見的感染之一，” 葛蘭素史克首席科學官 Tony Wood 在新聞稿中表示。“我們為開發 Blujepa 感到自豪，這是近三十年來首個用於 uUTIs 的新類口服抗生素，為面臨復發感染和現有治療耐藥率上升的患者提供了另一種選擇。”</p>
<p>批准是基於 III 期隨機、多中心、雙盲、雙假藥、非劣效性 EAGLE-2 和 EAGLE-3 試驗的結果，這些試驗評估了 Blujepa 的療效和安全性。在試驗中，EAGLE-2 的 1,531 名患者和 EAGLE-3 的 1,605 名患者以 1:1 的比例隨機分配接受 Blujepa（劑量為每天兩次 1,500 毫克）或硝呋太爾（劑量為每天兩次 100 毫克）。研究的主要終點是在對硝呋太爾敏感的細菌患者中，治療反應在治癒測試（第 10-13 天）時的表現。1,2</p>
<p>EAGLE-2 確認 Blujepa 的療效不劣於硝呋太爾，接受 Blujepa 的患者中有 50.6% 取得了治療成功，而硝呋太爾組為 47%。在 EAGLE-3 中，Blujepa 顯示出統計學上的優越性，治療成功率為 58.5%，而硝呋太爾組為 43.6%。</p>
<p>接受 Blujepa 治療的患者中，最常見的不良事件（AEs）為胃腸道反應，包括腹瀉和噁心。在所有胃腸道不良事件中，69% 為輕度，28% 為中度，3% 為重度。Blujepa 的安全性和耐受性特徵與之前的臨牀試驗一致。</p>
<p>根據葛蘭素史克的數據，uUTIs 每年影響美國多達 1600 萬女性，使其成為女性中最常見的細菌感染。全球範圍內，超過 50% 的女性在其一生中會經歷 uUTI，其中 30% 的人還會經歷至少一次復發。</p>
<p>Blujepa 在美國的商業推出預計將在今年下半年進行。該項目的開發部分由美國衞生與公眾服務部、戰略準備與響應管理局、生物醫學先進研究與發展局以及國防威脅減少局資助。1</p>
<p>根據_Medscape_的報道，20 至 40 歲女性中有 25% 至 40% 在其一生中至少經歷過一次尿路感染。此外，尿路感染在過去一年內導致超過 600 萬次就醫，其中 20% 的病例是在急診科報告的。女性的尿路感染髮生率隨着年齡的增長而增加。然而，18 至 30 歲的女性如果經歷過蜜月膀胱炎或懷孕，更容易發展為尿路感染。在絕經後女性中，由於膀胱或子宮脱垂導致膀胱排空不完全，尿路感染的發生率往往增加。3</p>
<p>“對於許多人來説，uUTIs 可能是嚴重影響日常生活的負擔，” 邁阿密大學醫學院臨牀醫學教授 Thomas Hooton 在新聞稿中表示。“隨着越來越多的患者經歷復發感染，持續研究抗微生物藥物以幫助解決患者面臨的挑戰和醫療系統的壓力仍然是明確的需求。”</p>
<p><strong>參考文獻</strong></p>
<p>1. Blujepa（gepotidacin）獲得美國 FDA 批准，用於治療女性成人和 12 歲及以上兒童的非複雜性尿路感染（uUTIs）。_GSK._2025 年 3 月 25 日。訪問日期：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 與硝呋太爾在非複雜性尿路感染患者中的比較（EAGLE-2 和 EAGLE-3）：兩項隨機、對照、雙盲、雙假藥、III 期非劣效性試驗。<em>ScienceDirect.</em> 訪問日期：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> 訪問日期：2025 年 3 月 26 日。https://emedicine.medscape.com/article/233101-overview#a5</p>

葛蘭素史克

<p>美國食品藥品監督管理局（FDA）已批准葛蘭素史克的 Blujepa（gepotidacin），這是一種首創的口服抗生素，用於治療女性和 12 歲以上患者的非複雜性尿路感染（uUTIs）。這標誌着近 30 年來首個用於 uUTIs 的新型口服抗生素的問世。臨牀試驗顯示，Blujepa 的療效顯著，與硝呋太爾相比，其治療成功率分別為 50.6% 和 58.5%。預計該藥物將在今年下半年在美國商業上市，解決每年影響數百萬女性的重大健康問題</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>圖片來源：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>美國 FDA 已批准葛蘭素史克的 Blujepa（gepotidacin），這是一種用於治療女性成人和 12 歲以上患者的非複雜性尿路感染（uUTIs）的首個口服抗生素。根據公司介紹，Blujepa 引入了一種新穎的作用機制，標誌着近 30 年來首個用於 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 的批准是一個重要的里程碑，因為 uUTIs 是女性中最常見的感染之一，” 葛蘭素史克首席科學官 Tony Wood 在新聞稿中表示。“我們為開發 Blujepa 感到自豪，這是近三十年來首個用於 uUTIs 的新類口服抗生素，為面臨復發感染和現有治療耐藥率上升的患者提供了另一種選擇。”</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>批准是基於 III 期隨機、多中心、雙盲、雙假藥、非劣效性 EAGLE-2 和 EAGLE-3 試驗的結果，這些試驗評估了 Blujepa 的療效和安全性。在試驗中，EAGLE-2 的 1,531 名患者和 EAGLE-3 的 1,605 名患者以 1:1 的比例隨機分配接受 Blujepa（劑量為每天兩次 1,500 毫克）或硝呋太爾（劑量為每天兩次 100 毫克）。研究的主要終點是在對硝呋太爾敏感的細菌患者中，治療反應在治癒測試（第 10-13 天）時的表現。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 確認 Blujepa 的療效不劣於硝呋太爾，接受 Blujepa 的患者中有 50.6% 取得了治療成功，而硝呋太爾組為 47%。在 EAGLE-3 中，Blujepa 顯示出統計學上的優越性，治療成功率為 58.5%，而硝呋太爾組為 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 治療的患者中，最常見的不良事件（AEs）為胃腸道反應，包括腹瀉和噁心。在所有胃腸道不良事件中，69% 為輕度，28% 為中度，3% 為重度。Blujepa 的安全性和耐受性特徵與之前的臨牀試驗一致。</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>根據葛蘭素史克的數據，uUTIs 每年影響美國多達 1600 萬女性，使其成為女性中最常見的細菌感染。全球範圍內，超過 50% 的女性在其一生中會經歷 uUTI，其中 30% 的人還會經歷至少一次復發。</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 在美國的商業推出預計將在今年下半年進行。該項目的開發部分由美國衞生與公眾服務部、戰略準備與響應管理局、生物醫學先進研究與發展局以及國防威脅減少局資助。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>根據_Medscape_的報道，20 至 40 歲女性中有 25% 至 40% 在其一生中至少經歷過一次尿路感染。此外，尿路感染在過去一年內導致超過 600 萬次就醫，其中 20% 的病例是在急診科報告的。女性的尿路感染髮生率隨着年齡的增長而增加。然而，18 至 30 歲的女性如果經歷過蜜月膀胱炎或懷孕，更容易發展為尿路感染。在絕經後女性中，由於膀胱或子宮脱垂導致膀胱排空不完全，尿路感染的發生率往往增加。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>“對於許多人來説，uUTIs 可能是嚴重影響日常生活的負擔，” 邁阿密大學醫學院臨牀醫學教授 Thomas Hooton 在新聞稿中表示。“隨着越來越多的患者經歷復發感染，持續研究抗微生物藥物以幫助解決患者面臨的挑戰和醫療系統的壓力仍然是明確的需求。”</p>
</div><p><strong>References</strong></p>
<div class="lb-trans"><p><strong>參考文獻</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）獲得美國 FDA 批准，用於治療女性成人和 12 歲及以上兒童的非複雜性尿路感染（uUTIs）。_GSK._2025 年 3 月 25 日。訪問日期：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 與硝呋太爾在非複雜性尿路感染患者中的比較（EAGLE-2 和 EAGLE-3）：兩項隨機、對照、雙盲、雙假藥、III 期非劣效性試驗。<em>ScienceDirect.</em> 訪問日期：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> 訪問日期：2025 年 3 月 26 日。https://emedicine.medscape.com/article/233101-overview#a5</p>
</div>

FDA 批准了葛蘭素史克的 Blujepa 用於治療非複雜性尿路感染