Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, London, UK.
Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, London, UK.
Clin Microbiol Infect. 2019 Jan;25(1):60-64. doi: 10.1016/j.cmi.2018.04.024. Epub 2018 Apr 30.
The paucity of licensed monoclonal antibodies (mAbs) in the infectious diseases arena strongly contrasts with the ready availability of these therapeutics for use in other conditions.
This narrative review aims to assess the potential of monoclonal antibody-based interventions for infectious diseases.
A review of the literature via the Medline database was performed and complemented by published official documents on licensed anti-infective mAbs. In addition, ongoing trials were identified through a search of the clinical trial registration platform ClinicalTrials.gov.
We identified the few infections for which mAbs have been added to the therapeutic armamentarium and stressed their potential in representing a readily available protection tool against biothreats and newly emerging and reemerging infectious agents. In reviewing the historical context and main features of mAbs, we assert a potentially wider applicability and cite relevant examples of ongoing therapeutic developments. Factors hindering successful introduction of mAbs on a larger scale are outlined and thoughts are offered on how to possibly address some of these limitations.
mAbs may represent important tools in treating or preventing infections occurring with reasonably sufficient prevalence to justify demand and for which existing alternatives are not deemed fully adequate. Future initiatives need to address the prohibitive costs encountered in the development process. The feasibility of more large-scale administration of alternative modalities merits further exploration. In order to ensure optimal prospect of regulatory success, an early dialogue with competent authorities is encouraged.
传染病领域可用的许可单克隆抗体(mAb)稀缺,而其他疾病领域则广泛应用这些治疗药物,两者形成鲜明对比。
本综述旨在评估基于单克隆抗体的干预措施在传染病中的潜力。
通过 Medline 数据库进行文献综述,并补充已发布的许可抗传染性 mAb 的官方文件。此外,通过搜索临床试验注册平台 ClinicalTrials.gov 确定了正在进行的试验。
我们确定了少数几种感染性疾病已经添加到治疗武器库中,并强调了它们在代表针对生物威胁以及新出现和重新出现的传染病的现成保护工具方面的潜力。在回顾 mAb 的历史背景和主要特征时,我们断言其具有潜在的更广泛适用性,并引用了正在进行的治疗开发的相关示例。概述了阻碍 mAb 大规模引入的因素,并就如何解决其中一些限制提出了一些想法。
mAb 可能是治疗或预防具有足够高流行率以证明需求合理性的感染的重要工具,而现有的替代方法被认为不完全足够。未来的举措需要解决开发过程中遇到的高成本问题。进一步探索更广泛应用替代模式的可行性是值得的。为了确保监管成功的最佳前景,鼓励与主管当局进行早期对话。