UTILITY has received a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024

公用事业公司已收到处方药用户费用法案（PDUFA），目标行动日期为2024年4月24日

FDA granted Qualified Infectious Disease Product (QIDP) designation for PIVYA in 2018, which provides an additional 5 years of data exclusivity upon approval

FDA于2018年授予PIVYA合格传染病产品（QIDP）称号，经批准后可提供额外5年的数据专有权

LONDON, UK / ACCESSWIRE / January 17, 2024 / UTILITY therapeutics Ltd., a biotechnology company focused on the development and commercialization of two European-approved antibiotics for the treatment of urinary tract infections (UTIs) in the U.S., today announced a private financing led by the AMR Action Fund.

英国伦敦/ACCESSWIRE/2024年1月17日/UTILITY therapeutics Ltd.，一家生物技术公司，专注于开发和商业化两种欧洲批准的用于治疗美国尿路感染（UTI）的抗生素，今天宣布由AMR行动基金领导的私人融资。

In addition, UTILITY announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for PIVYA (pivmecillinam) for the treatment of uncomplicated UTIs (uUTI)..

此外，公用事业公司宣布，美国食品和药物管理局（FDA）已接受其用于治疗无并发症UTI（uUTI）的PIVYA（pivmecillinam）新药申请（NDA）。。

The FDA granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024.

FDA批准优先审查NDA，处方药使用费法案（PDUFA）的目标行动日期为2024年4月24日。

Pivmecillinam is a European-approved, oral prodrug of mecillinam. Pivmecillinam has a unique mechanism of action and targets penicillin binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria. UTILITY has received the FDA's qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI.

Pivmecillinam是一种欧洲批准的美西林口服前药。Pivmecillinam具有独特的作用机制，靶向革兰氏阴性菌细胞壁中的青霉素结合蛋白-2（PBP-2）。公用事业公司已获得FDA的合格传染病产品（QIDP）指定用于治疗uUTI的pivmecillinam。

The FDA's QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and it provides an additional five years of market exclusivity..

FDA的QIDP指定用于治疗严重或危及生命的感染的抗菌和抗真菌候选药物，它提供了另外五年的市场独占性。。

'The number of safe, effective antibiotics that clinicians have at their disposal continues to dwindle in the face of rising rates of antimicrobial resistance,' said AMR Action Fund CEO Henry Skinner, PhD. 'Bringing pivmecillinam to the U.S. will give clinicians an important tool to help patients suffering from urinary tract infections and support efforts to enhance global access to this drug.'.

AMR行动基金（AMR Action Fund）首席执行官亨利·斯金纳（HenrySkinner）博士（PhD.）说，面对不断上升的抗菌素耐药性，临床医生可以使用的安全有效的抗生素数量继续减少将pivmecillinam带到美国将为临床医生提供一个重要工具，以帮助患有尿路感染的患者，并支持加强全球获得这种药物的努力。”。

'We are grateful to the AMR Action Fund for its leadership and support to bring this much-needed antibiotic to the US market for uUTI,' said Tom Hadley, President and CEO of UTILITY therapeutics. 'We believe that PIVYA can be utilized as a first-line therapy where many of the current therapeutic options are limited due to efficacy, safety, and/or rising rates of resistance.

实用治疗公司总裁兼首席执行官汤姆·哈德利（TomHadley）说，我们感谢AMR行动基金（AMR Action Fund）的领导和支持，将这种急需的抗生素带入美国uUTI市场我们认为PIVYA可以用作一线治疗，其中许多当前的治疗选择由于疗效，安全性和/或耐药率上升而受到限制。

Given there has not been a new antibiotic approved in the U.S. for the treatment of uUTI in over 20 years, the priority review by the FDA for PIVYA is an important step to providing a new option to physicians and patients as antimicrobial resistance continues to rise.'.

鉴于20多年来美国尚未批准用于治疗uUTI的新抗生素，FDA对PIVYA的优先审查是为医生和患者提供新选择的重要一步，因为抗菌素耐药性持续上升。”。

'This unique mechanism leads to favorable stability against beta-lactamase hydrolysis compared to other penicillins. In more than 30 million courses of treatment administered across Europe, oral pivmecillinam has demonstrated strong clinical cure rates with no serious adverse events observed, while maintaining a low resistance rate of approximately 5%,' said Professor Morten Sommer, co-founder of UTILITY..

“与其他青霉素相比，这种独特的机制对β-内酰胺酶水解具有良好的稳定性。UTILITY联合创始人莫滕·索默（MortenSommer）教授说，在欧洲3000多万个疗程的治疗中，口服匹维西林表现出很高的临床治愈率，没有观察到严重的不良事件，同时保持了约5%的低耐药率。。

About UTILITY therapeutics Ltd.

关于UTILITY therapeutics Ltd。

UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that is being developed for uncomplicated UTI (uUTI), and it has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases.

公用事业公司拥有两种欧洲批准的用于治疗尿路感染（UTI）的抗生素pivmecillinam和mecillinam的美国独家商业权利。Pivmecillinam是一种美西林的口服前药，正在开发用于无并发症的UTI（uUTI），它对革兰氏阴性菌（包括超广谱β-内酰胺酶）引起的感染具有独特的作用机制。

Mecillinam, an intravenous (IV) formulation, is being developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting..

Mecillinam是一种静脉注射（IV）制剂，正在开发中，作为医院环境中复杂UTI（CUI）的一线治疗方法。。

UTILITY has received the FDA's qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI, and IV mecillinam followed by oral pivmecillinam as step-down, carbapenem-sparing therapy for cUTI. This therapeutic regimen allows patients to complete their treatment outside of hospital and reduces the economic burden of cUTI to both patients and payers.

该公司已获得FDA的合格传染病产品（QIDP）指定，用于治疗uUTI的pivmecillinam，以及IV mecillinam，然后口服pivmecillinam作为CUI的降压，碳青霉烯保留疗法。这种治疗方案允许患者在医院外完成治疗，并减轻患者和付款人的cUTI经济负担。

The FDA's QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and provides an additional five years of market exclusivity and potentially includes Priority Review..

FDA的QIDP指定用于治疗严重或危及生命的感染的抗菌和抗真菌候选药物，并提供额外的五年市场排他性，并可能包括优先审查。。

For additional information, please visit www.utilitytherapeutics.com.

有关更多信息，请访问www.utilitytherapetics.com。

Contact

联系人

Tom Hadley

汤姆·哈德利

Chief Executive Officer

首席执行官

Tel: +1 (973) 224-7272

电话：+1（973）224-7272

info@utilitytherapeutics.com

info@utilitytherapeutics.com

SOURCE: Utility therapeutics Ltd.

资料来源：实用疗法有限公司。

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