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.

美国食品药品监督管理局 （FDA） 认识到，抗微生物药物的医疗需求尚未得到满足，用于治疗由耐药病原体引起的严重细菌性疾病，而这些疾病的有效疗法有限或缺乏。该机构还认识到，设计和开展临床试验以评估治疗耐药性感染的药物的安全性和有效性具有挑战性，尤其是对于仅对单一或几种细菌物种有效的药物，更灵活的开发计划可能是合适的。在本文中，我们讨论了旨在满足未满足的医疗需求的抗菌药物灵活开发计划的几个监管考虑因素。例如，我们以最近批准的注射用舒巴坦和注射用度洛巴坦 （XACDURO） 为例，用于治疗由鲍曼不动杆菌-钙醋酸杆菌复合体的敏感分离株引起的医院获得性细菌性肺炎和呼吸机相关细菌性肺炎。