Summary of the US FDA Approval of Belatacept

被引：78
|
作者：
Archdeacon, P. [3 ]
Dixon, C. [2 ]
Belen, O. [1 ]
Albrecht, R. [1 ]
Meyer, J. [1 ]
机构：
[1] US FDA, Div Transplant & Ophthalmol Prod, Off Antimicrobial Prod, Off New Drugs,Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
[2] US FDA, Div Biometr 4, Off Biostat, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
[3] US FDA, Off Med Policy, Drug Evaluat & Res, Rockville, MD 20857 USA
来源：
AMERICAN JOURNAL OF TRANSPLANTATION | 2012年 / 12卷 / 03期
关键词：
Belatacept; clinical trials; efficacy; endpoints; safety; PHASE-III; CYCLOSPORINE; IMMUNOSUPPRESSION; BENEFIT;
D O I：
10.1111/j.1600-6143.2011.03976.x
中图分类号：
R61 [外科手术学];
学科分类号：
摘要：
Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example.
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收藏
页码：554 / 562
页数：9
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