The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States

Summary The approval of orphan anticancer drugs in Japan has increased to meet high social demand. Drug lag, namely the approval lag of new drugs, is recognized as a social issue in Japan. We investigated the approval lag and its components, submission lag and review-time lag, between Japan and the...

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Bibliographic Details
Published in:Investigational new drugs 2019-10, Vol.37 (5), p.1086-1093
Main Authors: Nakayama, Hiroki, Matsumaru, Naoki, Tsukamoto, Katsura
Format: Article
Language:English
Subjects:
Antineoplastic Agents - therapeutic use
Antineoplastic drugs
Antitumor agents
Cancer
Clinical Trials, Phase III as Topic
Collaboration
Correlation coefficient
Correlation coefficients
Drug Approval - legislation & jurisprudence
Drug Approval - statistics & numerical data
Drug development
Drugs
Humans
Japan
Medicine
Medicine & Public Health
Neoplasms - drug therapy
Oncology
Orphan Drug Production - legislation & jurisprudence
Orphan Drug Production - statistics & numerical data
Pharmacology/Toxicology
Phase III Studies
Time Factors
Time lag
United States
United States Food and Drug Administration
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Summary:Summary The approval of orphan anticancer drugs in Japan has increased to meet high social demand. Drug lag, namely the approval lag of new drugs, is recognized as a social issue in Japan. We investigated the approval lag and its components, submission lag and review-time lag, between Japan and the United States (US) to reveal whether an approval lag still exists, and to identify potential factors that may contribute to reducing the approval lag. Anticancer drugs approved in Japan between April 2004 and November 2017 were investigated using publicly available information. Results showed that the median approval lag of orphan anticancer drugs in 2016–2017 was 727.0 days (interquartile range, IQR, 310.0–1054.3). The approval lag was significantly correlated with the submission lag (correlation coefficient = 1.00, P  
ISSN:0167-6997
1573-0646
DOI:10.1007/s10637-018-0612-y