Monday, October 28, 2024, at 8:30 a.m. EDT
DUBLIN and CHICAGO, Oct. 28, 2024 /PRNewswire/ --
WHO: | Iterum Therapeutics plc (Nasdaq: ITRM) is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. |
WHAT: | Conference call to discuss U.S. Food and Drug Administration (FDA) approval of Iterum's ORLYNVAH (Oral Sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs). Speakers include: Corey Fishman (CEO) and Steve Aronin (Senior Vice President and Head of Clinical Development |
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WHY: | ORLYNVAH (sulopenem etzadroxil and probenecid) is the first oral penem approved for use in the U.S. and the first FDA-approved product for Iterum. ORLYNVAH is approved for the treatment of uUTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. It is only the second FDA-approved treatment for uUTIs in the past two decades. For more details, view the press release issued Friday here. |
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WHEN: | Monday, October 28, 2024 8:30 a.m. Eastern Daylight Time |
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| Dial-in information: United States: +1 833-470-1428 | International: +1 404-975-4839 Access code: 936149 |
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| The conference call replay will be available in the Events & Presentations page of Iterum's website following the call. |
About Iterum Therapeutics plc
Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit .
SOURCE Iterum Therapeutics plc
2024年10月28日星期一上午8:30美国东部时间
2024年10月28日,都柏林和芝加哥/美国东部时间,
谁: | iterum therapeutics plc (纳斯达克: ITRM)致力于提供 专注于研发不同化的抗感染药物,旨在应对全球的多药耐药病原体危机 显著改善世界各地受严重和危及生命疾病影响的人们的生活。 全球各地存在严重且危及生命的疾病。 |
事件: | 电话会议讨论美国食品和药物管理局 (FDA) 批准 iterum therapeutics的ORLYNVAH (口服Sulopenem) 用于治疗不复杂的 泌尿道感染 (uUTIs)。 演讲嘉宾包括:Corey Fishman (首席执行官) 和Steve Aronin (高级副 总裁兼临床开发负责人 |
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为什么: | ORLYNVAH(sulopenem etzadroxil和probenecid)是第一种口服penem化合物 在美国获批准使用,也是iterum首个获得FDA批准的产品 ORLYNVAH被批准用于治疗由指定微生物Escherichia coli、Klebsiella pneumoniae或Proteus mirabilis引起的uUTIs 在成年女性中,这些微生物导致的尿路感染,这些女性没有或有限的其他口服抗菌治疗 成年女性,这些微生物导致的尿路感染,这些女性没有或有限的其他口服抗菌治疗 期权。这是过去两年中第二个获得FDA批准的治疗复合物尿路感染的方法 几十年。 欲了解更多详情,请查看周五发布的新闻稿 |
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WHEN: | 2024年10月28日星期一 美国东部夏令时间上午8点30分 |
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| 拨入信息: 美国:+1 833-470-1428 | 国际:+1 404-975-4839 访问码:936149 |
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| 会议电话重播将在iterum therapeutics网站的“活动与演示”页面上提供。 |
关于Iterum Therapeutics plc
Iterum Therapeutics plc专注于提供不同的抗感染药物,旨在应对全球多耐药病原体危机,显著改善受严重和威胁生命疾病影响的人们的生活。Iterum正在推进其首个化合物——sulopenem的研发,这是一种新型的penem抗感染化合物,具有口服和静脉注射制剂。Sulopenem已在体外显示出对各种耐其他抗生素的革兰氏阴性、革兰氏阳性和厌氧细菌具有强效活性。Iterum已获得ORLYNVAH(口服sulopenem)的新药申请批准,用于治疗由指定微生物埃希菌、肺炎克雷伯菌或美丽变形杆菌引起的成年女性患有无选择或无其他口服抗菌治疗选项的非并发性尿路感染。该药品已获得美国食品和药物管理局的合格传染病产品(QIDP)和快速通道标志,用于其七种适应症的口服和静脉注射制剂。欲了解更多信息,请访问。
SOURCE iterum therapeutics plc