GSK has helped top up the antibiotic armamentarium in the US, after securing the first FDA approval for an oral carbapenem, Utebzi, for adults with complicated urinary tract infections (cUTIs).

葛兰素史克（GSK）在获得美国食品药品监督管理局（FDA）对首个口服碳青霉烯类药物Utebzi的批准后，帮助充实了美国的抗生素武器库，该药适用于患有复杂性尿路感染（cUTI）的成人患者。

While it doesn't offer a novel mechanism of action, Utebzi (tebipenem pivoxil) – which GSK licenses from Spero Therapeutics – provides an oral alternative to the current intravenously administered carbapenems, which are often used as a last resort for infections resistant to other antibiotics.

虽然Utebzi（tebipenem pivoxil）并未提供全新的作用机制，但作为葛兰素史克从Spero Therapeutics获得许可的药物，它为当前静脉注射的碳青霉烯类药物提供了一种口服替代方案。碳青霉烯类药物通常被用作对其他抗生素产生耐药性的感染患者的最后治疗手段。

That means patients may be able to reduce hospital stays or visits to an infusion centre, and potentially be treated entirely at home, which could reduce the risk of patients with cUTIs being exposed to other infections and potentially cut healthcare costs.

这意味着患者可能能够缩短住院时间或减少前往输液中心的次数，并有可能完全在家中接受治疗，从而降低复杂性尿路感染（cUTI）患者接触其他感染的风险，并可能降低医疗成本。

'For patients with…cUTIs and their caregivers, this approval is a major milestone as today's standard of care places a serious burden on them and hospitals,' commented Dr Bilal Chughtai, a senior urologist working at Plainview Hospital and Hofstra University/Northwell Health in the US.

“对于复杂性尿路感染（cUTI）患者及其照护者而言，此次批准是一个重要的里程碑，因为当前的标准治疗方案给他们和医院带来了沉重的负担。”在美国普莱恩维尤医院以及霍夫斯特拉大学/诺斯韦尔健康系统工作的资深泌尿科医生比拉尔·丘格泰博士评论道。

'A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings,' he added.

“一种新的有效口服治疗方案为静脉治疗提供了替代选择，有望在门诊环境中实现更多治疗。”他补充道。

GSK

葛兰素史克

acquired rights

既得权利

to Utebzi in a $591 million deal in 2022, just a few months after the FDA rejected Spero's first marketing application for the antibiotic with a request for an additional clinical trial.

在2022年，以5.91亿美元的交易出售给Utebzi，这仅仅是在美国食品药品监督管理局（FDA）因要求补充一项临床试验而拒绝Spero公司该抗生素的首个上市申请几个月之后。

That study – called

那项研究——被称为

PIVOT-PO

枢轴采购订单

– compared Utebzi to a standard therapy of IV imipenem-cilastatin for cUTIs, including pyelonephritis, and showed that the two regimens were equally effective at achieving a clinical cure and eradicating the bacteria causing the infection, with a 'generally similar' safety profile.

– 将Utebzi与静脉注射亚胺培南-西司他丁的标准疗法进行了比较，后者用于治疗复杂性尿路感染（cUTI），包括肾盂肾炎。研究结果显示，两种方案在实现临床治愈和根除致病菌方面效果相当，且安全性“总体相似”。

There are estimated to be around 29 million cUTI cases in the US alone every year, many of which are caused by multidrug-resistant (MDR) pathogens, and can result in organ failure, sepsis, and death.

据估计，仅在美国，每年就有约2900万例复杂性尿路感染（cUTI）病例，其中许多由多重耐药（MDR）病原体引起，可能导致器官衰竭、败血症和死亡。

According to GSK, cUTIs cost US health systems around $6 billion a year to manage, with emergency department visits and hospitalisations a significant contributor.

据葛兰素史克（GSK）称，美国医疗系统每年用于治疗复杂性尿路感染（cUTIs）的费用约为60亿美元，其中急诊就诊和住院是主要费用来源。

The company – one of the few big pharma companies to still be actively working on new antimicrobials – said it expects to make Utebzi available to patients in the US with cUTIs by the end of the year.

该公司——少数仍在积极研发新型抗菌药物的大型制药企业之一——表示，预计将在年底前向美国复杂性尿路感染（cUTIs）患者提供Utebzi。

Last year, GSK also won two FDA approvals for the first-in-class triazaacenaphthylene antibiotic,

去年，葛兰素史克（GSK）还获得了美国食品药品监督管理局（FDA）对首款同类首创的三氮杂苊烯类抗生素的两项批准，

Blujepa

布鲁杰帕

(gepotidacin), firstly for cUTIs and then for uncomplicated gonorrhoea. In 2023, the company licensed rights to a novel triterpenoid antifungal approved for yeast infections,

（吉泊达星），首先用于复杂性皮肤及软组织感染（cUTIs），随后用于无并发症淋病。2023年，该公司授权了一项新型三萜类抗真菌药物的权利，该药已获批用于治疗酵母菌感染，

Brexafemme

布雷沙芬

(ibrexafungerp), from Scynexis in a $593 million deal.

(ibrexafungerp)，来自Scynexis公司，交易金额为5.93亿美元。

While pharma companies have argued for years that it is very difficult to get a return on investment in antimicrobial medicines, GSK has suggested its three new products could collectively generate peak sales of more than £2 billion a year.

尽管制药公司多年来一直声称，抗微生物药物很难获得投资回报，但葛兰素史克（GSK）表示，其三款新产品合计的年峰值销售额有望超过20亿英镑。

Image by

图片由

zes dho

六

from

从

Pixabay

Pixabay