Characteristics of Newly Approved Drugs in Japan and/or the United States from 2001 to 2020 Based on Discovery Research by Academia

Abstract

Objective: In recent years, with changes in the drug discovery environment, academia-discovered drugs have been the focus of much attention. In this study, we surveyed the characteristics of academia-discovered drugs that have been approved in Japan and/or the United States (US) in the last 20 years to understand the current status and discuss the encouragement of development. Method: This study comprehensively collected information on academia-discovered drugs approved in Japan and/or the US from 2001 to 2020, analyzed their characteristics, and discussed similarities and differences between countries. Result: A total of 73 academia-discovered drugs were approved during the last 20 years, 68 in the US, 47 in Japan and 42 in both countries. Pharmaceuticals with various modalities have been approved continuously, with an increasing number of biologic products in the last five years. These drugs were mainly for therapeutic purposes, and more than 60% received some type of priority review. The initial indications were across a variety of disease areas, but the treatment of “neoplasms” and “endocrine, nutritional or metabolic diseases” was numerous. In this study, that reviewed the academia-discovered drugs approved in Japan and the US, the US accounted for 70% of the academics who have critical patents of the drug and companies responsible for the early clinical development of drugs. There were 17 products approved in the US that were not developed in Japan. Five products were approved only in Japan, but all except Borofalan were developed in the US. Conclusion: In recent years, many academia-discovered drugs for cancer and rare diseases have been approved in Japan and/or the US, and biologic products have increased. To promote academia-discovered drugs in Japan like the US, it is important to invest abundant R & D expenditures, establish a strong R & D ecosystem, and bridge the gap from academia to companies in charge of clinical development.