美国食品和药物管理局批准了Nikimvo (axatilimab-csfr) 用于治疗成人和儿童慢性移植对宿主疾病. The FDA approved Niktimvo (axatilimab-csfr) for treating chronic graft-versus-host disease in adult and pediatric patients.

美国食品和药物管理局批准了Niktimvo(axatilimab-csfr),在至少前两条系统治疗线失败后,对体重至少40公斤的成人和儿科病人进行慢性移植寄生虫病(GVHD)的治疗。 The U.S. FDA has approved Niktimvo (axatilimab-csfr), a treatment for chronic graft-versus-host disease (GVHD) in adult and pediatric patients weighing at least 40 kg, after failure of at least two prior lines of systemic therapy. 根据AGAAVE-201研究的数据,CSF1-R阻塞抗体Axatilimab展示了所有器官和病人分组的持久反应。 Based on data from the AGAVE-201 study, axatilimab, a CSF1-R-blocking antibody, demonstrated durable responses across all organs and patient subgroups. 林业发展局的核准旨在解决与慢性GVHD有关的严重并发症,这些并发症影响到美国约17 000名病人。 The FDA approval aims to address the severe complications related to chronic GVHD, affecting approximately 17,000 patients in the U.S.