Recent Trends and Success Factors in Reducing the Lag Time to Approval of New Drugs in Japan

Honig, P K

doi:10.1038/clpt.2013.256

Cited by 25 publications

(24 citation statements)

References 6 publications

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“…e Not reported. for Japan to participate in multinational clinical trials have been increasing 16,17 and GT strategy could also be expected to reduce the cost of clinical trials in Japan, 18 the relationship between Japan's participation in global clinical trials and reduction in drug lag has been attracting attention in oncology drug development. Our finding that the number of drugs approved with a strategy for a global clinical trial including Japan steadily increased and that this became one of the main styles of clinical development of oncology drugs approved after 2011 is also a good signal for Japan from the above point of view.…”

Section: Discussionmentioning

confidence: 99%

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Kogure

Koyama

Hidaka

2017

The Journal of Clinical Pharma

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Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies.

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Section: Discussionmentioning

confidence: 99%

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Kogure

Koyama

Hidaka

2017

The Journal of Clinical Pharma

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“…Historically, the Japanese government had approved newly-developed medications after a long time lag of about 2 years since the medication has been approved in many other countries. 17 , 18 Various explanations have been provided for this. The government weighed checking the safety profile of the new medication in other countries against the merit of delivering the new medication sooner.…”

Section: Introductionmentioning

confidence: 99%

Role of combined indacaterol and glycopyrronium bromide (QVA149) for the treatment of COPD in Japan

Horita

Kaneko

2015

COPD

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Once-daily dual-bronchodilator therapy with combined indacaterol and glycopyrronium bromide in one device (Ultibro, Breezhaler), often called QVA149, was first approved in 2013 in Japan and Europe. As of November 2014, more than 40 countries had approved this medication except for the USA. This is the first dual bronchodilator in one device. Now, the Breezhaler is the only device that can provide long-acting muscarinic antagonist (glycopyrronium bromide), long-acting beta agonist (indacaterol), and a combination of the two medications (QVA149). The choice among the three medications allows a patient to use the same inhalation device even when the regimen is changed from single-bronchodilator therapy to dual-bronchodilator therapy. In addition, the quick bronchodilation effect and once-daily administration can improve patient adherence to medical treatment for chronic obstructive pulmonary disease (COPD). To our knowledge, as of November 2014, the safety and the efficacy of QVA149 have been evaluated in 14 randomized controlled trials. The 14 trials generally showed good safety profiles, and there were better or not-inferior bronchodilator effects of QVA149 when compared with placebo, or other inhaled medication. According to the Japanese Respiratory Society guidelines, QVA149 is a combination of the two first-line bronchodilators. Our meta-analysis indicated that QVA149 is superior to the salmeterol–fluticasone combination to treat COPD in respect of the frequency of adverse effects, exacerbation, pneumonia, and improvement of trough forced expiratory volume in 1 second (FEV1). Thus, we believe that QVA149 can be a key medication for COPD treatments.

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“…In recent years, more GCTs are including Japanese patients especially in pivotal trials. 48 The PMDA and the MHLW advocate that the inclusion of GCTs for Japanese drug approval would reduce the drug lag. As for the staffing of the PMDA, published materials report that there was a threefold increase in 2013 from the less than 200 staff numbers of the review and safety section in 2004.…”

Section: Introductionmentioning

confidence: 99%

A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

Tanimoto¹

2015

DDDT

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The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals (“Yakugai” in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and development of novel therapeutics in Japan, further reforms should be explored for patients who need new and emerging pharmaceuticals.

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Recent Trends and Success Factors in Reducing the Lag Time to Approval of New Drugs in Japan

Cited by 25 publications

References 6 publications

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Role of combined indacaterol and glycopyrronium bromide (QVA149) for the treatment of COPD in Japan

A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

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