Furie Richard
New York University School of Medicine, New York, NY, USA.
Rheum Dis Clin North Am. 2006 Feb;32(1):149-56, x. doi: 10.1016/j.rdc.2005.11.001.
Abetimus sodium has been under development for the treatment of systemic lupus erythematosus since the early 1990s. Because its administration results in the selective reduction of circulating double-stranded DNA antibodies, La Jolla Pharmaceutical Company has focused on the agent's ability to prolong time to nephritic flare. Fourteen trials have been initiated since 1994, but the two pivotal registration trials failed to meet primary end points. The US Food and Drug Administration issued a letter in October 2004 that stated abetimus sodium was "approvable" pending the successful completion of a trial demonstrating clinical benefit. The fate of this agent lies in the ability of the company to successfully complete a phase III study.
自20世纪90年代初以来,阿贝替莫钠就一直在研发用于治疗系统性红斑狼疮。由于其给药可导致循环双链DNA抗体选择性减少,拉霍亚制药公司一直专注于该药物延长肾炎发作时间的能力。自1994年以来已开展了14项试验,但两项关键的注册试验未能达到主要终点。美国食品药品监督管理局于2004年10月发出一封信函,称在一项证明临床益处的试验成功完成之前,阿贝替莫钠“可获批”。该药物的命运取决于公司能否成功完成一项III期研究。