Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Okubo, Tomoko Kawamura; Ono, Shunsuke

doi:10.1111/cts.12631

Cited by 5 publications

(2 citation statements)

References 23 publications

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“…Yamada et al (2010) indicated the benefit of access to safety data accumulated in other countries as a trade-off for delay in access to new drugs in Japan [32]. Okubo et al (2019) reported that drugs developed under a bridging strategy tended to show lower risks, and that local clinical studies may play a substantial role in achieving optimization of post-marketing drug use [24]. In addition, a case-by-case discussion with the PMDA may support flexible drug development and allow regulators making a flexible decision upon drug approval.…”

Section: Discussionmentioning

confidence: 99%

Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan

Nagasawa

Aruga

2020

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The term 'drug lag' represents the difference in the timing of drug approval among countries. The impact of accelerated approvals on the drug lag for anticancer drugs between the United States (U.S.) and Japan was evaluated using publicly available information to identify anticancer drugs approved in the U.S. or Japan between January 2006 and March 2017. A logistic regression analysis was conducted to determine the association between the oncology drugs lags and potential factors, including accelerated approval. The median drug lag was 805 days. The drug lag was extended for drugs that were approved in the U.S. under accelerated approval (884 days) compared to the standard approval (606 days). A total of 170 approvals were available for the analysis of drug lags. A multivariate logistic regression analysis revealed that the following factors contributed significantly to the drug lags (p < 0.05): accelerated approval (odds ratio [OR] 4.48), Phase III study (OR 3.69), major cancer (OR 0.38), and international/global development (OR 0.32). Accelerated approval in the U.S. is one of the significant factors that extend the drug lags for anticancer drugs. The current drug development and approval process in Japan may have advantages, however, since a new regulation to reduce drug lag for anticancer drugs, the conditional early approval system, may help minimize drug lags and support decision making not only for regulators but also pharmaceutical companies. https://doi.org/10.21423/jrs-v08nagasawa

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Section: Discussionmentioning

confidence: 99%

Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan

Nagasawa

Aruga

2020

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“…Moreover, it has been reported that the local development optimized to medical environments in Japan have provided important evidence and improved appropriate post-marketing use [26,27]. For example, the national health/medical insurance system in Japan allows patients to obtain approved drugs easily, therefore participating in clinical trials to receive non-approved drugs may not be attractive from risk and benefit perspective compared to approved drug treatment.…”

Section: Mrct May Become a Solution Of Development Initiation Lagmentioning

confidence: 99%

Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials

2021

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Background Drug time lags occur between the date that new drugs are first approved, often in the USA, and approval is granted in other countries. Multi-regional clinical trials (MRCTs) are a key strategy for simultaneous global development and regulatory submission of new drugs. However, no studies have evaluated the impact of MRCT versus local development on key time points in the drug development lifecycle between the USA and Japan. It is important for pharmaceutical companies planning drug development in Japan to understand when they can start development, when they can catch up in case of development initiation delay, length of time the development period might take, and amount of time that market exclusivity is lost, if Japan does not participate in the MRCT. Objective The aim of this study was to investigate differences in drug lag in development initiation, New Drug Application (NDA) submission and drug approval, as well as differences in the development and review periods, by local trials and MRCTs between Japan and the USA. We also assessed the advantages and disadvantages of MRCTs for these lags in Japan. Methods We analyzed drug approvals in Japan between 2016 and 2020 and divided them into local and MRCT groups. Lags in development initiation, NDA submission, and approval of new drugs were calculated by subtracting each date in Japan from the corresponding date in the USA. Our study period was divided into three periods based on the International Conference on Harmonization (ICH) E17 guideline, published in 2017, and the guideline for the Phase I trials in the Japanese population prior to MRCTs, published in 2014. In addition, subgroup analyses by therapeutic area, regulatory background, modality, capital style, and sales ranking (2020) were conducted. ResultsWe analyzed 174 approvals in Japan and the USA. The differences in the drug lags for development initiation, NDA submission, and approval between the local and MRCT groups were 4.9, 3.5, and 3.2 years, respectively. All three lag times were shorter for the MRCT group than the local group. A development initiation lag in the local group has expanded since publication of the guidelines. Conclusions For the people of Japan, important drug lags were identified in development initiation, NDA submission, and drug approval dates between local trials and MRCTs that include Japan. It is difficult to recover fully from the delay caused by local development, and it is important to understand the further expansion of drug lags, in cases where Japan is not involved in the MRCT.

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A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018

Sumi

Asada

Lü

et al. 2020

Clinical Therapeutics

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Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Cited by 5 publications

References 23 publications

Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan

Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan

Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials

A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018

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