基于生物标志物的过敏性疾病和哮喘药物研发：美国食品药品监督管理局公开研讨会
Biomarker-driven drug development for allergic diseases and asthma: An FDA public workshop.
作者信息
Rabin Ronald L, Altman Matthew C, Arshad S Hasan, Beger Richard D, Frischmeyer-Guerrerio Pamela A, Goleva Elena, Hamilton Robert G, Khurana Hershey Gurjit K, Shamji Mohamed H, Sampson Hugh A, Santos Alexandra F, Shreffler Wayne G, Togias Alkis, Vieths Stefan, Wambre Erik, Wenzel Sally E, Hise Kathleen, Lee Joohee, Tripathi Anubha, Slater Jay E
机构信息
Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.
University of Washington, Seattle, Wash.
出版信息
J Allergy Clin Immunol. 2025 Jun;155(6):1753-1766. doi: 10.1016/j.jaci.2025.03.014. Epub 2025 Mar 26.
The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, National Institutes of Health staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into 3 sessions: (1) FDA and European Union regulators discussing regulatory perspectives on use of biomarkers in drug development programs, (2) investigators discussing biomarkers for pediatric and adult asthma, and (3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.
美国食品药品监督管理局（FDA）于2024年2月22日举办了一场研讨会，以讨论生物标志物在过敏性哮喘和食物过敏药物研发中的现状。该研讨会为监管机构人员、学者、国立卫生研究院工作人员和行业人士提供了一个开放的讨论平台，旨在向利益相关者通报FDA采用生物标志物作为临床试验替代终点的要求，并向FDA通报各种正在研发的生物标志物的情况。研讨会分为3个环节：（1）FDA和欧盟监管机构讨论药物研发项目中生物标志物使用的监管观点；（2）研究人员讨论儿童和成人哮喘的生物标志物；（3）研究人员讨论食物过敏的生物标志物。在本报告中，我们回顾了研讨会上展示的信息，并总结了这些过敏性疾病潜在生物标志物的现状。
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