Increased understanding of the immunopathology of inflammatory bowel disease (IBD) has resulted in the development of novel therapies such as vedolizumab or ustekinumab, and the investigation of new agents including Janus kinase inhibitors, anti-mucosal vascular addressin cell adhesion molecule-1 agents, anti-interleukin-12/23 monoclonal antibody and sphingosine-1-phosphate receptor-1 selective agonists.1 Over the last years, new approaches to mentoring drug research and testing have been developed. Among these methods, the fast-track drug designation and subsequent approval of safe regimens represent an emerging drug development approach in IBD treatment.2 Since 2001, the European Commission has started a fast-track approval programme for the European Medicines Agency (EMA). The Committee for Human Medicinal Products, established under the EMA, is responsible for such an accelerated review process.2 The requirements and time frames for approval of a drug under the accelerated review process are similar to those used by the United States Food and Drug Administration authorities (FDA). Eligibility for fast-track (in the USA) or accelerated approval (EMA) is based on whether a product will be of major public health interest, particularly from the point of view of therapeutic innovation3 and on endpoints that predict substantial clinical improved outcomes.2 In IBD, this can be difficult to define and the gold standard would probably be complete mucosal or histological healing.2 The cost of IBD care is rising worldwide as IBD incidence and prevalence are rapidly increasing.4 One key reason for the rising cost of IBD treatment is the significant costs of new therapeutic molecules brought into the market, particularly biologics.2 4 Indeed, evidence suggests that the cost of biologic agents now accounts for the main expenditure in treating patients with IBD.5 6 To reduce the cost of IBD drugs, efforts must be made to optimise the drug development process and …

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IBD 药物开发的挑战和机遇：从早期到监管批准

对炎症性肠病 (IBD) 免疫病理学的更多了解导致了新疗法的开发，如维多珠单抗或优特克单抗，以及新药物的研究，包括 Janus 激酶抑制剂、抗粘膜血管地址蛋白细胞粘附分子 1 药物、抗-interleukin-12/23 单克隆抗体和 1-磷酸鞘氨醇受体-1 选择性激动剂。1 在过去的几年里，已经开发出指导药物研究和测试的新方法。在这些方法中，快速通道药物指定和随后安全方案的批准代表了 IBD 治疗中一种新兴的药物开发方法。2 自 2001 年以来，欧盟委员会已经启动了欧洲药品管理局 (EMA) 的快速通道批准计划。EMA 下设立的人类医药产品委员会，负责此类加速审评流程。2 加速审评流程下批准药物的要求和时间框架与美国食品药品监督管理局 (FDA) 使用的要求和时间框架类似。快速通道（在美国）或加速批准 (EMA) 的资格取决于产品是否具有重大的公共卫生利益，特别是从治疗创新的角度 3 和预测临床显着改善结果的终点。 2在 IBD 中，这可能很难定义，金标准可能是完全的粘膜或组织学愈合。2 随着 IBD 发病率和患病率的迅速增加，IBD 护理的成本在全球范围内不断上升。