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

The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United... Investigational New Drugs https://doi.org/10.1007/s10637-018-0612-y PHASE III STUDIES The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States 1 2 2 Hiroki Nakayama & Naoki Matsumaru & Katsura Tsukamoto Received: 6 April 2018 /Accepted: 24 May 2018 Springer Science+Business Media, LLC, part of Springer Nature 2018 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 < 0.001) but not with the review-time lag (correlation coefficient = −0.16, P = 0.22). The submission lag was significantly longer http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Investigational New Drugs Springer Journals

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

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Publisher
Springer US
Copyright
Copyright © 2018 by Springer Science+Business Media, LLC, part of Springer Nature
Subject
Medicine & Public Health; Oncology; Pharmacology/Toxicology
ISSN
0167-6997
eISSN
1573-0646
D.O.I.
10.1007/s10637-018-0612-y
Publisher site
See Article on Publisher Site

Abstract

Investigational New Drugs https://doi.org/10.1007/s10637-018-0612-y PHASE III STUDIES The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States 1 2 2 Hiroki Nakayama & Naoki Matsumaru & Katsura Tsukamoto Received: 6 April 2018 /Accepted: 24 May 2018 Springer Science+Business Media, LLC, part of Springer Nature 2018 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 < 0.001) but not with the review-time lag (correlation coefficient = −0.16, P = 0.22). The submission lag was significantly longer

Journal

Investigational New DrugsSpringer Journals

Published: May 31, 2018

References

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