治疗性重组蛋白：1982年至2002年美国批准情况的趋势

Therapeutic recombinant proteins: trends in US approvals 1982 to 2002.

作者信息

Reichert Janice M, Paquette Cherie

机构信息

Tufts Center for the Study of Drug Development, Suite 550, 192 South Street, Boston, MA 02111, USA.

出版信息

Curr Opin Mol Ther. 2003 Apr;5(2):139-47.

PMID:12772503

Abstract

Recombinant proteins have become an important class of therapeutics since the first product was approved for marketing in the US in 1982. To determine trends in the clinical development and approval processes for therapeutic recombinant proteins, data for 270 products that entered clinical study in the period 1980 to 2002 were collected and analyzed. Mean clinical and approval phase lengths for 54 US-approved products stratified by time period, therapeutic indication, protein type, review rating and FDA review center are compared. Approval success rates, calculated using three methods that differ only in the definition of success, and the variation of approval success rates over five time periods are presented.

摘要

自1982年首个产品在美国获批上市以来，重组蛋白已成为一类重要的治疗药物。为了确定治疗性重组蛋白临床开发和审批流程的趋势，我们收集并分析了1980年至2002年期间进入临床研究的270种产品的数据。比较了按时间段、治疗适应症、蛋白类型、审评评级和美国食品药品监督管理局（FDA）审评中心分层的54种美国获批产品的平均临床和审批阶段时长。给出了使用三种仅在成功定义上有所不同的方法计算出的获批成功率，以及五个时间段内获批成功率的变化情况。