Analysis of labeling decisions on therapeutic indication during new drug reviews in Japan
Analysis of labeling decisions on therapeutic indication during new drug reviews in Japan
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日本新药审评期间治疗适应症标签决策分析
DOI：
10.1038/clpt.2011.134
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发表时间：
2011
影响因子：
6.7
通讯作者：
et al.
中科院分区：
文献类型：
--
作者：
Masafumi Yokota;et al.
我们分析了日本的监管审查，以研究针对建议的治疗适应症在药物标签方面所做的修改，并调查了与这些变化相关的因素，以深入了解这些决定背后的原因。在2000年至2009年期间日本批准的220个新的分子实体(NME)中，有70个获得了比申请者提出的更多的限制性适应症和14个扩大的适应症。多项回归分析表明，除了与疗效数据的充分性有关的因素外，市场上存在的竞争药物、更高的估计峰值销售额和拟议适应症的更高复杂性是显著增加适应症在审查中受到限制的可能性的因素。我们的结果为我们提供了一个线索，即批准的治疗适应症如何在提交的数据包中反映申请者的特征、药物、审查领域(RAS)和临床证据，以及决定背后的原则。DOI：10.1038/clpt.2011.134
We analyzed regulatory reviews in Japan to study the modifications made in drug labeling with respect to proposed therapeutic indications, and investigated factors associated with these changes so as to gain insight into the reasons behind the decisions. Of 220 new molecular entities (NMEs) approved in Japan from 2000 to 2009, 70 received more restricted indications and 14 received more expanded indications than those proposed by the applicants. Multinomial regression analysis suggested that the presence of competitive drugs in the market, higher estimated peak sales, and higher complexity of the proposed indication were factors that significantly increased the likelihood of the indications being restricted on review, in addition to factors related to adequacy of efficacy data. Our results give us a clue to how the approved therapeutic indications reflect the characteristics of the applicants, drugs, review areas (RAs), and clinical evidence in the submitted data package, as well as to the principle behind the decisions.Clinical Pharmacology & Therapeutics(2011)903, 432–441. doi:10.1038/clpt.2011.134