Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous CONTEPO™ for InjectionPDUFA action date set for June 19, 2020

Nabriva Therapeutics收到FDA确认静脉抗生素CONTEPO™的新药申请书

2020-01-09 07:20:12 BioSpace

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Nabriva Therapeutics plc , a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration  has acknowledged receipt of its New Drug Application resubmission for marketing approval of CONTEPO™ for injection for the treatment of complicated urinary tract infections . In the acknowledgement letter for the resubmitted NDA, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter the FDA issued on April 30, 2019. As a result, the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of June 19, 2020 for the completion of its review of the NDA. CONTEPO is a potential first-in-class intravenous antibiotic in the U.S. for the treatment of cUTIs. The NDA resubmission is supported by data from a pivotal Phase 2/3 clinical trial (known as ZEUS™), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis. Complicated Urinary Tract Infection Complicated urinary tract infection (cUTI) occurs when Gram-negative bacteria are embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. Patients who are being treated for a urinary tract infection and fail to respond to an initial course of antibiotics can go on to develop a cUTI.  Among the causes of cUTI is Enterobacteriaceae, which is a multi-drug resistance (MDR) strain of Gram-negative bacteria. Enterobacteriaceae produces extended spectrum beta-lactamases (ESBL), a chemical that can cause some antibiotics to be ineffective in treating bacterial infections such as cUTI. As a result, cUTI poses a serious and rapidly emerging health threat for hospitalized patients, especially those in intensive care units. About CONTEPO CONTEPO (fosfomycin) for injection is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections. About Nabriva Therapeutics plc Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for intravenous use in the United States for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit https://www.nabriva.com. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its plans for and timing and potential outcome of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the development of CONTEPO for cUTI, the clinical utility of CONTEPO for cUTI, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to resolve the matters set forth in the Complete Response Letter it received from the FDA in connection with its NDA for CONTEPO (fosfomycin) for injection; Nabriva Therapeutics’ reliance on third-party manufacturers to manufacture the clinical and commercial supply of its product candidates and the ability of such third parties to comply with applicable regulatory requirements; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of its acquisition of Zavante Therapeutics, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release. CONTACTS: For Investors Gary Sender Nabriva Therapeutics plc IR@Nabriva.com For Media Mike Beyer Sam Brown Inc. mikebeyer@sambrown.com 312-961-2502
Nabriva Therapeutics plc ,一家从事开发创新抗感染药物治疗严重感染的商业化阶段生物制药公司,宣布美国食品药品监督管理局(Food and Drug Administration)已确认收到其用于治疗复杂尿路感染的注射用 CONTECO ™的新药申请再提交上市许可。 在重新提交 NDA 的确认函中, FDA 表示 Nabriva 的备案是对 FDA 于2019年4月30日发布的完整回复函的完整的第2类回复。因此, FDA 设定了处方药用户费用法案( PDUFA )的目标日期为2020年6月19日,以完成其对 NDA 的审查。 CONTECO 是一种潜在的一流静脉抗生素,在美国治疗 cUTI 。NDA 的再次提交得到了关键2/3期临床试验(称为 ZEUS ™)的数据的支持,该试验满足了 cUTI 患者包括急性肾盂肾炎在内的哌拉西林/他唑巴坦的统计非劣效性的主要终点。 复杂的尿路感染 当革兰氏阴性细菌嵌入膀胱壁时,复杂的尿路感染( cUTI )就会发生,在膀胱壁中,革兰氏阴性细菌的繁殖速度更慢,更难用抗生素治疗。正在接受泌尿系统感染治疗但未对最初的抗生素疗程作出反应的患者可以继续发展 cUTI 。 引起 cUTI 的原因之一是肠杆菌科,它是一种革兰氏阴性细菌的多重耐药( MDR )菌株。肠杆菌科产生广谱β-内酰胺酶( ESBL ),一种化学物质,可以导致一些抗生素无效的治疗细菌感染,如 cUTI 。因此, cUTI 对住院病人,特别是重症监护病房的病人构成了严重和迅速出现的健康危害。 关于 CONTECO 注射用 CONTECO (磷霉素)是一种新型的、潜在的美国一流的静脉注射抗生素,具有广泛的革兰氏阴性和革兰氏阳性活性。包括对大多数当代耐多药( MDR )菌株的活性,例如产生肠杆菌科的广谱β-内酰胺酶( ESBL )。IV fofofoxin 已获得多项适应症的批准,并在美国以外的45年内用于治疗各种感染,包括 cUTI 和其他严重细菌感染。 关于 Nabriva Therapeutics plc Nabriva Therapeutics 是一家生物制药公司,从事创新抗感染药物的商业化和开发,以治疗严重感染。Nabriva Therapeutics 获得了美国食品药品监督管理局(Food and Drug Administration)批准的 XENLETA ™( Lemamulin ),这是第一种用于社区获得性肺炎( CABP )的全身性多磺酸抗生素。Nabriva Therapeutics 公司也正在开发注射用 CONTECO ™( fofoxin ),这是一种有望在美国静脉注射的第一类环氧乙烷抗生素,用于治疗包括急性肾盂肾炎在内的复杂泌尿道感染。详情请访问 https://www.nabiriva.com 。 前瞻性陈述 本新闻稿中有关 Nabriva Therapeutics 的未来预期、计划和前景的任何声明,包括但不限于关于其对 CONTECO 监管备案审核的计划、时间安排和潜在结果的声明、将 CONTECO 推向市场的努力、 CONTECO 用于 CTI 的开发、CONEPO 用于 cUTI 的临床用途, XENLETA 用于 CABP 和 CONEPO 用于 cUTI 的市场机会和潜在市场接受, XENLETA 和 CONEPO 用于附加适应症的开发, XENLETA 和 CONEPO 的额外制剂的开发,计划进行其他候选产品的研究和开发,Nabriva Therapeutics 现有现金资源的充足性及其对其现有现金资源未来多长时间的预期,将为其持续经营和其他报表提供资金,这些报表包含“预期”、“相信”、“估计”、“预期”、“打算”、“可能”、“计划”、“预测”、“项目”、“目标”、“可能”、“未来”、“可能”、“将”、“可以”、“应该”、“应该”、“继续”等字样,构成1995年《私人证券诉讼改革法案》意义内的前瞻性陈述。实际结果可能因各种重要因素而与该等前瞻性陈述所示的结果有重大差异,包括: Nabriva Therapeutics 有能力解决其从 FDA 收到的与注射用 CONTECO (磷霉素)的 NDA 有关的完整回复函件中所述事项; Nabriva Therapeutics 依赖第三方制造商制造其产品候选药物的临床和商业供应,以及此类第三方遵守适用监管要求的能力;美国食品药品监督管理局(Food and Drug Administration)和其他监管机构所作决定的内容和时间安排, Nabriva Therapeutics 实现其收购 Zavante Therapeutics 的预期效益、协同增效作用和增长前景的能力,临床试验启动和开展过程中固有的不确定性,临床试验数据的可得性和时间安排,早期临床试验结果或不同疾病适应症的研究结果是否将表明正在进行的或未来的试验结果、与临床试验的监管审查和上市批准申请相关的不确定性、 CONTECO 治疗 cUTI 的可用性或商业潜力、保留和雇用关键人员的能力,根据可接受的条款或任何其他重要因素提供充足的额外融资,如 Nabriva Therapeutics 提交给美国证券交易委员会的年度和季度报告以及其他备案文件中所述。此外,本新闻稿中包含的前瞻性陈述代表了 Nabriva Therapeutics 截至本新闻稿发布之日的观点。Nabriva Therapeutics 预计,后续事件和发展将导致其观点发生变化。然而,尽管 Nabriva Therapeutics 可能选择在未来某个时刻更新这些前瞻性陈述,但它明确表示不承担任何这样做的义务。这些前瞻性陈述不应被视为代表 Nabriva Therapeutics 截至本新闻稿发布日期之后的任何日期的观点。 合同内容: 对投资者而言 Gary Sender Nabriva Therapeutics plc IR @ Nabriva.com 适用于媒体 Mike Beyer 山姆布朗公司。 mikebeyer @ sambrown.com 312-961-2502

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