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Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

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Abstract

Background

The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union

Methods

Information about approved antidiabetic drugs was obtained by searching databases of regulatory authorities in the 3 regions. Other relevant information was also obtained from publicly available literature and documents

Results

No difference in the total number and types of approved drugs among the 3 regions was found (P =.173 by log-rank test). However, the numbers of approved dipeptidyl peptidase-4 and sodium-glucose cotransporter 2 inhibitors in Japan were almost double of those in the other regions. The average sample size in clinical trials used for antidiabetic drug approval in Japan (1134 patients) was much smaller than that in the other regions (P <.001 by analysis of variance repeated measures test adjusted by the Holm method). Currently, 6 drugs with known modes of action are being developed for type 1 diabetes in Japan, whereas at the end of 2016, nearly 7-fold more products with novel modes of action were in clinical development in the United States

Conclusion

Antidiabetic drug development in Japan costs less than that in the other regions, although novel development is less active because of regulatory differences. To achieve better pharmacotherapy for diabetes, the regulatory framework requires careful consideration

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Authors and Affiliations

  1. Global Regulatory Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu, 501-1196, Japan

    Katsura Tsukamoto PhD, Daichi Mori MSc & Naoki Matsumaru PhD

  2. ULB Center for Diabetes Research, and Division of Endocrinology, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium

    Miriam Cnop MD, PhD

  3. School of Life Science and Technology, Tokyo Institute of Technology, Yokohama, Japan

    Shoen Kume PhD

  4. Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan

    Takayuki Anazawa MD, PhD

  5. Naruto Research Institute, Otsuka Pharmaceutical Factory, Inc, Tokushima, Japan

    Masako Doi PhD

  6. Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

    Kazuhiko Chikazawa BSc

Authors
  1. Katsura Tsukamoto PhD
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  2. Miriam Cnop MD, PhD
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  3. Daichi Mori MSc
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  4. Shoen Kume PhD
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  5. Takayuki Anazawa MD, PhD
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  6. Masako Doi PhD
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  7. Kazuhiko Chikazawa BSc
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  8. Naoki Matsumaru PhD
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Corresponding author

Correspondence to Katsura Tsukamoto PhD.

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Tsukamoto, K., Cnop, M., Mori, D. et al. Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework. Ther Innov Regul Sci 53, 535–541 (2019). https://doi.org/10.1177/2168479018795854

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  • DOI: https://doi.org/10.1177/2168479018795854

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