Drug Lag for Inflammatory Bowel Disease Treatments in the East and West

Abstract

Background: Inflammatory bowel disease (IBD), though historically common in the West, is now increasingly prevalent in industrializing countries. A simultaneous dramatic increase in IBD drug options has enabled most patients to achieve remission. Nevertheless, worldwide disparities in the approval of IBD drugs, or "drug lag", remain problematic.

Summary: Drug lag for major IBD drugs before March 31, 2018 (12 for Crohn's disease [CD] and 13 for ulcerative colitis [UC]) was compared between that of the United States (US), European Union (EU), and Asia (Japan, China, South Korea, Taiwan, and the Philippines) to assess current trends. In the US, unapproved IBD drugs accounted for 16.7% (2/12) for CD and 23.1% (3/13) for UC; approval lag was 3.8 (0-80.5) months for CD and 3.6 (0-88) months for UC. In the EU, unapproved drugs accounted for 16.7% (2/12) for CD and 15.4% (2/13) for UC; approval lag was 0.03 (0-13.9) months for CD and 0 (0-13.9) months for UC. This demonstrates the short drug lag in both regions, although one drug developed in a joint US/EU clinical trial had around a 350-day approval lag. In Asia, the proportion of unapproved IBD drugs was the lowest in Japan at 33.3% (4/12) for CD and 23.1% (3/13) for UC; South Korea had the shortest lag for CD at 13.2 (0-133.1) months and the Philippines had the shortest lag for UC at 9.9 (0.6-176.2) months, but these countries still had longer lag periods than the West. However, a proportion of unapproved drugs and approval lag has decreased considerably in Asia since the start of the biologics era.

Key messages: Despite the recent shortening drug lag between different countries and regions, this study shows that disparities persist. With globalization, eliminating these disparate drug lags is necessary to manage IBD and may require efforts toward international adoption of a more standardized approval process.

Keywords: Approval lag; Crohn's disease; Drug approval; Drug lag; Inflammatory bowel disease; Ulcerative colitis.

Fig. 1

Comparison of median drug approval lag values between Asian countries before and after the start of the biologics era. Approval lag was significantly shorter for drugs developed in the biologics era in Japan, South Korea, and the Philippines (Mann-Whitney U test). a Japan (p = 0.0005). b South Korea (p = 0.0003). c Taiwan (p = 0.127). d The Philippines (p = 0.0357). * p < 0.05 (p value determined by Mann-Whitney U test).