Tanaka Makoto, Matsumaru Naoki, Tsukamoto Katsura
1 Global Regulatory Science, Gifu Pharmaceutical University, Gifu, Japan.
2 Development Project Management, Astellas Pharma Inc, Tokyo, Japan.
Ther Innov Regul Sci. 2019 Mar;53(2):199-206. doi: 10.1177/2168479018769288. Epub 2018 May 6.
Recent trends in globalization and the complexity of drug development have resulted in the possibility that expedited programs in one country may now influence drug development in another. We examined the effects of expedited programs in the United States on the development of oncology drugs in Japan.
Among oncology drugs approved in Japan between 2007 and 2016, we analyzed those that were approved in both the United States and Japan. The development period was calculated by subtracting the start date of the first clinical study or the investigational new drug application date from the drug approval date in the respective country. All data were obtained from publicly disclosed information.
We analyzed a total of 108 approvals for oncology drugs. The difference in the development start date between the United States and Japan for drugs granted Breakthrough Therapy designation was smaller than that for drugs without this designation ( P < .01). The development period in Japan for drugs granted Breakthrough Therapy, Accelerated Approval or Fast Track designations was significantly shorter than that for drugs without these designations ( P < .05). In addition, the development period of oncology drugs in Japan tended to be significantly shorter as the number of expedited program designations increased ( P < .006 for trend).
The characteristics and the target disease of the drug that could be eligible for expedited program(s) in the United States, which was supported by the designation, were one of the factors influencing the development of oncology drugs in Japan.
全球化的最新趋势以及药物研发的复杂性导致一个国家的加速审批程序如今可能会影响另一个国家的药物研发。我们研究了美国的加速审批程序对日本肿瘤药物研发的影响。
在2007年至2016年期间于日本获批的肿瘤药物中，我们分析了那些在美国和日本均获批的药物。研发周期通过用各自国家的药物批准日期减去首次临床研究开始日期或研究性新药申请日期来计算。所有数据均从公开披露的信息中获取。
我们总共分析了108项肿瘤药物批准。获得突破性疗法认定的药物在美国和日本的研发开始日期差异小于未获得该认定的药物（P <.01）。在日本，获得突破性疗法、加速批准或快速通道认定的药物的研发周期显著短于未获得这些认定的药物（P <.05）。此外，随着加速审批程序认定数量的增加，日本肿瘤药物的研发周期往往显著缩短（趋势P <.006）。
在美国有资格获得加速审批程序认定的药物的特性和目标疾病，在该认定的支持下，是影响日本肿瘤药物研发的因素之一。
