Emerg Infect Dis. 2024 Nov;30(11):2227-2230. doi: 10.3201/eid3011.231416.
The US Food and Drug Administration recognizes the unmet medical need for antibacterial drugs to treat serious bacterial diseases caused by resistant pathogens for which effective therapies are limited or lacking. The agency also recognizes that designing and conducting clinical trials to assess the safety and efficacy of drugs to treat resistant infections is challenging, especially for drugs only active against a single or a few bacterial species, and that a more flexible development program might be appropriate. In this article, we discuss several regulatory considerations for flexible development programs for antibacterial drugs intended to meet an unmet medical need. As an example, we use the recent approval of sulbactam for injection and durlobactam for injection (XACDURO) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
美国食品和药物管理局认识到，存在未满足的医疗需求，需要抗菌药物来治疗由耐药病原体引起的严重细菌病，而有效的治疗方法有限或缺乏。该机构还认识到，设计和进行临床试验以评估治疗耐药感染的药物的安全性和疗效具有挑战性，尤其是对于仅对单一或少数几种细菌物种具有活性的药物，并且更灵活的开发计划可能更为合适。在本文中，我们讨论了针对旨在满足未满足医疗需求的抗菌药物的灵活开发计划的几个监管考虑因素。作为一个例子，我们使用最近批准的注射用舒巴坦和注射用多利培南（XACDURO）来治疗由鲍曼不动杆菌-醋酸钙复合物种敏感分离株引起的医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎。
