Sulopenem

iStock, hapabapa Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders. The FDA on Friday signed off on Iterum Therapeutics’ oral antibiotic sulopenem etzadroxil and probenecid, which will now be marketed as Orlynvah, for the treatment of uncomplicated urinary tract infections in adult women. Orlynvah, Iterum’s first FDA-approved product, is cleared for three designated microorganisms— Escherichia coli , Klebsiella pneumoniae and Proteus mirabilis —and is indicated for women with limited or no available alternative oral antibiotic options. Iterum CEO Corey Fishman in a statement called Orlynvah’s approval a “historic milestone” that “offers new hope for patients suffering from difficult-to-treat uUTIs (uncomplicated urinary tract infections).” Orlynvah is “the first oral penem approved in the U.S.,” Fishman said, noting it is “an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians.” To bring Orlynvah to the market and boost its commercialization efforts, Iterum will “renew” its “efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders,” Fishman said. The FDA’s decision on Friday was backed by Iterum’s clinical data for Orlynvah, including two Phase III trials. In the pivotal late-stage REASSURE study, topline data which were released in January 2024 , the oral sulopenem showed statistical non-inferiority to Augmentin (amoxicillin/clavulanate) in terms of overall response. Orlynvah significantly outperformed Augmentin at overall treatment success. Safety outcomes were comparable between treatment groups. Iterum’s data package also included findings from the pivotal Phase III SURE 1 study, which in June 2020 showed that the oral sulopenem was better than ciprofloxacin in patients with quinolone-resistant infections. SURE 1 also found Orlynvah to be safe, with adverse events developing at a comparable frequency as in the ciprofloxacin-treated group. Iterum filed a New Drug Application to the FDA but failed to secure approval. In July 2021, the regulator handed the Dublin, Ireland-based biotech a Complete Response Letter, noting that while SURE 1 had established that oral sulopenem was superior than ciprofloxacin, Iterum would need to run an additional trial that uses a different comparator drug. Iterum filed its resubmission earlier this year, after which the FDA convened its Antimicrobial Drugs Advisory Committee. The panel was not asked to vote on the approvability of Orlynvah, but Fishman said in a statement after the meeting that the company was “encouraged” by the discussion, “which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI.”

▎药明康德内容团队编辑 Iterum Therapeutics今日宣布，美国FDA已批准其药品Orlynvah（sulopenem etzadroxil & probenecid）用于治疗由指定微生物（大肠杆菌、肺炎克雷伯菌或奇异变形杆菌）引起的无并发症尿路感染（uUTIs）成年女性，这类患者没有或几乎没有可替代口服抗菌治疗方案。根据新闻稿，Orlynvah是FDA批准的首个口服培南类抗生素，也是过去二十年中第二款获得FDA批准的uUTI治疗药物。 FDA的批准主要基于两项关键3期临床试验SURE 1和REASSURE的结果。这两项试验分别评估Orlynvah与环丙沙星和Augmentin抗生素相较，用以治疗uUTI成人女性患者的安全性和疗效。SURE 1研究显示Orlynvah在对抗氟喹诺酮耐药性感染方面优于活性对照药物，而REASSURE研究则显示在对Augmentin敏感的人群中，Orlynvah与活性对照药物相比达非劣效性，且在统计学上具有显著优势。Orlynvah在SURE 1和REASSURE临床试验中均表现出良好的耐受性。 ▲REASSURE研究的主要疗效数据（图片来源：参考资料[2]） Iterum Therapeutics公司开发的Orlynvah是一款可以口服也可以注射的广谱培南类（又称碳青霉烯类）抗生素。在体外试验中，它对已经对其它抗生素产生抗性的革兰氏阴性、革兰氏阳性和厌氧细菌都具有活性。 了解更多FDA获批新药 请点击下图访问我们的小程序 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections. Retrieved October 25, 2024 from https://www.globenewswire.com/news-release/2024/10/25/2969543/0/en/Iterum-Therapeutics-Receives-U-S-FDA-Approval-of-ORLYNVAH-Oral-Sulopenem-for-the-Treatment-of-Uncomplicated-Urinary-Tract-Infections.html [2] Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections. Retrieved February 1, 2024, from https://www.prnewswire.com/news-releases/iterum-therapeutics-announces-positive-topline-results-from-its-phase-3-reassure-clinical-trial-of-oral-sulopenem-in-uncomplicated-urinary-tract-infections-302047483.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新