FDA Approval Of Orlynvah For Urinary Tract Infections Marks Milestone For Iterum, Paves Way For New Strategic Partnerships
FDA Approval Of Orlynvah For Urinary Tract Infections Marks Milestone For Iterum, Paves Way For New Strategic Partnerships
SURE 1 showed superiority to ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin susceptible population.On Friday, Iterum Therapeutics plc (NASDAQ:ITRM) received FDA approval for its Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections (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.
周五，iterum therapeutics公司（纳斯达克:ITRM）获得FDA批准，用于治疗由指定的微生物埃希氏菌、克雷伯氏菌或奇异假单胞菌引起的成年妇女患有限或无其他口服抗菌药物治疗选择的非复杂性尿路感染（uUTIs）的Orlynvah（舒洛培南依扎卓胶囊和普罗本希胺）。
This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.
这是Orlynvah的首个获批适应症，也是Iterum的第一个FDA批准的产品。
The FDA approval was based on a clinical development program, including two Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of Orlynvah compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in the treatment of adult women with uUTI.
FDA的批准基于一项临床开发计划，包括两项第3期临床试验（称为SURE 1和REASSURE），评估Orlynvah在治疗成年女性患有限或无其他口服抗菌药物治疗选择的uUTI中与环丙沙星（SURE 1）和劳氨罗(REAURE)的安全性和有效性。
SURE 1 showed superiority to ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin susceptible population.
SURE 1显示出对氟喹诺酮耐药感染的优越性，而REASSURE显示出在对劳氨罗敏感人群中对劳氨罗的非劣效性和统计学优越性。
"The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians," said Corey Fishman, Iterum's CEO.
“引入新产品，如Orlynvah，是对其他已批准口服药物的抗微生物耐药性的重要对抗方式，为患者和医生提供了潜在解决方案，”Iterum的CEO Corey Fishman表示。
"As the first oral penem approved in the U.S., Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders."
“作为美国批准的首个口服喹诺酮类药物，Orlynvah为服务不足的uUTI市场中的适当患者提供了优秀的替代治疗选择。随着FDA的批准和明确的标签，我们将重新努力实现涉及Orlynvah的战略交易，旨在为利益相关者最大化价值。”
In July 2021, the FDA issued a Complete Response Letter (CRL) regarding sulopenem etzadroxil/probenecid (oral sulopenem).
2021年7月，FDA发布了有关舒洛培南依扎卓胶囊/普罗本希胺（口服舒洛培南）的完整答复函（CRL）。
The FDA determined that additional data are necessary to support approval.
FDA判断需要更多数据来支持批准。
The agency asked for at least one additional clinical trial, potentially using a different comparator drug, and conduct a further non-clinical investigation to determine the optimal dosing regimen.
该机构要求至少进行一项额外的临床试验，可能使用不同的比较药物，并进行进一步的非临床研究以确定最佳的给药方案。
Price Action: ITRM stock is down 14.7% at $1.604 at last check Monday.
股价走势：ITRm股价在上周一最后一次检查时下跌了14.7%，至1.604美元。
Image via Shutterstock
图片来自shutterstock。
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