食品和药物管理局公开研讨会总结-解决吸入抗真菌药物开发中的挑战
Caroline J Jjingo1, Shukal Bala1, Ursula Waack1
1Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
开发用于严重的真菌肺部感染的吸入性抗真菌疗法,如过敏性支气管肺性阿斯伯吉洛症,具有挑战性. 美国食品和药物管理局 (FDA) 的研讨会确定了关键障碍,并讨论了改善药物开发和临床试验的策略.
科学领域:
- 肺部医学 肺部医学
- 传染性疾病 传染性疾病
- 药物开发 药物开发
背景情况:
- 过敏性支气管肺性阿斯伯吉洛症和侵入性真菌病导致严重的疾病和死亡.
- 目前的吸入性抗真菌治疗缺乏批准,有效性有限,并引起不良影响.
- 抗真菌耐药性是治疗这些肺部真菌感染的日益关注的问题.
研究的目的:
- 为应对开发用于真菌肺部疾病的吸入性抗真菌药物的挑战.
- 讨论监管激励措施,改善非临床模型和临床试验设计.
- 收集专家对患者观点和行业挑战的见解.
主要方法:
- 2020年9月25日召开美国食品和药物管理局 (FDA) 研讨会.
- 汇集了来自学术界,工业界和政府的肺部医学和传染病专家.
- 讨论重点集中在吸入抗真菌开发的监管,临床前和临床试验方面.
主要成果:
- 确定了吸入抗真菌药物的非临床模型和临床试验设计的重大挑战.
- 强调需要制定监管激励措施,以促进新型吸入性抗真菌药物和设备的开发.
- 承认患者群体的异质性和这些真菌病的低患病率.
结论:
- 对肺部真菌感染改善的吸入性抗真菌疗法非常需要.
- 解决研究模型和临床试验方法的局限性对于进步至关重要.
- 合作努力和监管支持对于克服开发有效吸入抗真菌治疗的障碍至关重要.
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