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Influence of Expedited Programs in the United States on Oncology Drug Development in Japan
Makoto Tanaka1,2, Naoki Matsumaru1, Katsura Tsukamoto1
11 Global Regulatory Science, Gifu Pharmaceutical University, Gifu, Japan.
Background:
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.
Methods:
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.
Results:
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).
Conclusions:
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.
Insights
US expedited programs, like Breakthrough Therapy designation, significantly shorten oncology drug development timelines in Japan. Increased designations correlate with faster drug approvals, impacting global drug development.
Area of Science:
- Pharmacoeconomics
- Global Health Policy
- Oncology Drug Development
Background:
- Globalization and complex drug development necessitate understanding international regulatory influences.
- Expedited programs in one country may impact drug development timelines in another.
- This study specifically examines US expedited programs' effects on Japanese oncology drug development.
Purpose of the Study:
- To evaluate the impact of United States expedited programs on the development duration of oncology drugs in Japan.
- To determine if US designations influence the speed of oncology drug approvals in Japan.
Main Methods:
- Analysis of 108 oncology drug approvals in Japan between 2007 and 2016, focusing on drugs also approved in the US.
- Calculation of development periods by comparing clinical study start dates or investigational new drug application dates to drug approval dates.
- Utilized publicly available data for all analyses.
Main Results:
- Oncology drugs with US Breakthrough Therapy designation had shorter development start date differences between the US and Japan.
- Development periods in Japan were significantly shorter for drugs with Breakthrough Therapy, Accelerated Approval, or Fast Track designations.
- A trend of significantly shorter development periods in Japan was observed as the number of US expedited program designations increased.
Conclusions:
- US expedited program designations are a significant factor influencing oncology drug development timelines in Japan.
- Drug characteristics and target diseases eligible for US expedited programs play a role in their impact on Japanese development.
- Findings highlight the interconnectedness of global regulatory pathways in accelerating oncology drug availability.
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