국내 및 미국 의약품 허가사항에 반영된 약물유전체 정보 분석

Differences in Pharmacogenomic Information Reflected in Approved Drug Labels of Korea and the United States

Pharmacogenomics (PGx) is a field of precision medicine that enables prediction of adverse reactions and efficacy of drugs based on genetic variation. Therefore, due to the availability of drug genomics information, personalized treatment has become possible. In this study, we analyzed the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling to identify the number of drugs with PGx biomarker information on their label that has been updated in June 2020. Simultaneously, we attempted to confirm and compare the drug genomics information in Korea. The drug information, including the genomics information, on the labels was verified, and then, the drugs were classified and compared with the ATC drug efficacy group in Korea and the United States. There were PGx-related descriptions on the product labels of 298 medicines in US. Especially in Korea, 147 drugs with a description on genomic information were identified. In this study, we showed that the antineoplastic and immunomodulating agents account for more than half of the drugs with the genomic information and description regarding the requirement or recommendation for genetic biomarker testing on their label. In Korea, a similar pattern has been observed; however, the number is smaller than that confirmed by the US FDA.