국내 및 미국 의약품 허가사항에 반영된 약물유전체 정보 분석

Abstract

Pharmacogenomics (PGx) is a field of precision medicine that enables prediction of adverse reactions andefficacy of drugs based on genetic variation. Therefore, due to the availability of drug genomics information, personalizedtreatment has become possible. In this study, we analyzed the FDA Table of Pharmacogenomic Biomarkers in DrugLabeling to identify the number of drugs with PGx biomarker information on their label that has been updated in June2020. Simultaneously, we attempted to confirm and compare the drug genomics information in Korea. The druginformation, including the genomics information, on the labels was verified, and then, the drugs were classified andcompared with the ATC drug efficacy group in Korea and the United States. There were PGx-related descriptions on theproduct labels of 298 medicines in US. Especially in Korea, 147 drugs with a description on genomic information wereidentified. In this study, we showed that the antineoplastic and immunomodulating agents account for more than half ofthe drugs with the genomic information and description regarding the requirement or recommendation for geneticbiomarker testing on their label. In Korea, a similar pattern has been observed; however, the number is smaller than thatconfirmed by the US FDA.