Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework. (July 2019)

• Record Type: Journal Article
• Authors: Tsukamoto, Katsura; Cnop, Miriam; Mori, Daichi; Kume, Shoen; Anazawa, Takayuki; Doi, Masako; Chikazawa, Kazuhiko; Matsumaru, Naoki
• Is Part Of: Therapeutic innovation & regulatory science. Volume 53:Number 4(2019:Jul.)
• Page Start: 535
• Page End: 541
• Publication Date: 2019-07
• Subjects: pharmacotherapy -- pharmaceutical approval -- regulatory guidance -- type 1 diabetes mellitus -- type 2 diabetes mellitus; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479018795854
• Languages: English
• ISSNs: 2168-4790

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.