GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.

葛兰素史克公司 (LSE/NYSE: GSK) 今天宣布，美国食品药物管理局 (FDA) 已批准Blujepa (gepotidacin) 用于治疗由以下易感微生物引起的无并发症尿路感染 (uUTI) 的成人女性 (≥40 公斤) 和儿科患者 (≥12 岁，≥40 公斤)：大肠杆菌、肺炎克雷伯菌、弗氏柠檬酸杆菌复合群、腐生葡萄球菌和粪肠球菌。

Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio.

Blujepa由葛兰素史克公司的科学家发现，是一种一流的口服抗生素，具有新颖的作用机制，是葛兰素史克公司传染病药物组合的一部分。

Tony Wood, Chief Scientific Officer, GSK, said: “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. 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.”

GSK 首席科学官Tony Wood表示：“ Blujepa获批是一个重要的里程碑，因为 uUTI 是女性最常见的感染之一。我们很自豪能够开发出Blujepa，这是近 30 年来首个用于治疗 uUTI 的新型口服抗生素，为反复感染且现有治疗耐药率不断上升的患者带来另一种治疗选择。”

uUTIs are the most common infection in women, impacting up to 16 million women in the US annually.1-4 Over half of all women are affected by uUTI in their lifetime,5 with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities.6 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates.

uUTI 是女性中最常见的感染，每年影响美国多达 1600 万女性。1-4超过一半的女性在其一生中受到 uUTI 的影响，5其中约 30% 的女性至少患有一次复发性发作，这会给患者带来沉重的负担，包括不适和日常活动受限。6由于耐药性细菌引起的uUTI数量不断增加，这可能导致更高的治疗失败率，因此需要新的治疗方法。

Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: “For many, uUTIs can be a burden that severely impacts daily life. 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.”

迈阿密大学医学院临床医学教授 Thomas Hooton 医学博士表示： “对许多人来说，uUTI 可能是一种严重影响日常生活的负担。随着越来越多的患者出现反复感染，显然仍需要继续研究抗菌药物，以帮助应对持续的患者挑战和医疗保健系统的压力。”

The approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)).

此项批准是基于关键 III 期 EAGLE-2 和 EAGLE-3 试验的积极结果，这两项试验表明，在确诊患有 uUTI 的女性成人（≥40 公斤）和儿童患者（≥12 岁，≥40 公斤）中，Blujepa 的治疗成功率不低于呋喃妥因，呋喃妥因是目前治疗 uUTI 的主要标准选择之一。在 EAGLE-2 试验中，Blujepa 的治疗成功率不低于呋喃妥因，50.6%（162/320）的参与者成功率高于呋喃妥因，而呋喃妥因的成功率仅为 47.0%（135/287）（协变量调整后的治疗差异为 4.3%，95% CI（-3.6, 12.1））。在 EAGLE-3 试验中，Blujepa显示出优于呋喃妥因的统计学优势（单侧 p 值为 0.0003）。 58.5% (162/277) 的参与者治疗成功，而呋喃妥因治疗成功率为 43.6% (115/264)（协变量调整治疗差异 14.6%，95% CI (6.4, 22.8)）。

The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in Blujepa participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the Blujepa group, the most common maximum severity was mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (Blujepa and nitrofurantoin) across the two trials.

Blujepa在 EAGLE-2 和 EAGLE-3 III 期试验中的安全性和耐受性特征与之前的试验一致。Blujepa 受试者报告的最常见不良事件 (AE)是胃肠道 (GI)。腹泻是最常见的（16% 的受试者），其次是恶心 (9%)。在Blujepa组报告 GI AE 的受试者中，最常见的最大严重程度是轻度（69% 为 1 级）和中度（28% 为 2 级）。发生 3 级 GI 事件的受试者占所有发生 GI 事件患者的 3%，发生率不到所有受试者的 1%。在两项试验中，每个治疗组（Blujepa 和呋喃妥因）均发生了一例与药物相关的严重不良事件。

US commercial launch is planned in 2H 2025.

美国商业发射计划于 2025 年下半年进行。

The development of Blujepa (gepotidacin) has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002.

Blujepa （gepotidacin）的开发部分由美国卫生与公众服务部、战略防范与响应管理局、生物医学高级研究与发展局 (BARDA) 提供的联邦资金资助，其他交易协议编号为 HHSO100201300011C，国防威胁降低局提供的联邦资金资助，协议编号为 HDTRA1-07-9-0002。