[ Title ]
- Use of Pharmacogenomics and Biomarkers in the Development of New Drugs for Alzheimer Disease in Japan
[ Journal ]
- CLINICAL THERAPEUTICS
[ Abstract ]
- Purpose: Pharmacogenomics (PGx) and biomarkers have been utilized for
improving the benefit/risk ratios of drugs and the efficiency of drug
development. In the development of drugs for Alzheimer disease (AD), a
number of clinical trials have failed to demonstrate clinical efficacy.
To overcome this circumstance, the importance of using PGx/biomarkers
for enhancing recruitment into clinical trials and for evaluating the
efficacy of treatments has been increasingly recognized. In this
article, the current status and examples of the use of PGx/biomarkers in
Japan for drug development are explained.
Methods: Guidelines, notifications, and administrative notices related
to PGx/biomaikers were downloaded from the Web sites of the
Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug
Administration, and the European Medicines Agency. Data from clinical
studies of AD drugs were obtained from the review reports of the PMDA.
To analyze the current status of the use of PGx/biomarkers in Japan,
"Issues to Consider in the Clinical Evaluation and Development of Drugs
for Alzheimer's Disease (Interim Summary)" was also downloaded from PMDA
Findings: There are 2 major measures of utilizing PGx/biomarkers for
drug development: (1) biomarker qualification and (2) companion
diagnostics. Recently, the PMDA issued a number of guidelines and
notifications for their practical use. Although examples of qualified
PGx/biomarkers and approved companion diagnostics are limited at
present, it is expected that the use of PGx/biomarkers for the
development of drugs against AD would increase.
Implications: For promoting the use of PGx/biomarkers in the development
of drugs against AD, PGx/biomarkers should be qualified as early as
possible. To that end, accumulating data on PGx/biomarkers from
nonclinical or clinical trials and the concurrent development of
reliable diagnostics in the early stage of the development process are
indispensable. It is important to strengthen collaboration among the
academia, industries, and regulatory agencies, followed by the
establishment of an effective guideline in the area of AD.
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