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.

Delay in Vaccine Access in ASEAN Countries

“…For the relative approval lag of all vaccines and SRA-first vaccines, the Asia-Pacific countries have a longer relative approval lag than the US and the EU. Our finding of the longer approval lag in Asia compared to the US and EU was consistent with previous studies that assessed the approval lag in cancer drugs in India [ 30 ], inflammatory bowel disease drugs in selected Asian countries (Japan, China, South Korea, Taiwan, and the Philippines) [ 28 ], and cardiovascular drugs in India [ 31 ]. The approval lag of vaccines in Asia may be because of the differences in vaccine regulatory requirements and processes in Asia-Pacific countries, compared to the US and EU.…”

“…Local clinical data help to identify racial differences and establish the optimal dosage [ 33 ], but it takes time to conduct local clinical trials and delays the approval of vaccines in Korea. However, global clinical trials can eliminate the need to conduct the new local clinical trials for approval [ 28 ]. In the past decades, the number of global clinical trials conducted in Korea has grown rapidly, which might help reduce drug approval lag [ 34 ].…”

“…Absolute approval lag is the percentage of newly approved vaccines in the countries of interest out of the total number of all studied vaccines. Relative approval lag is the delay in approval in a study country after the drug’s first approval [ 28 ].…”

Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis

“…Currently, adalimumab, infliximab, and golimumab, which target TNF-α, and vedolizumab, which blocks recruitment of immune cells to the gut by targeting α 4 β 7 integrin, 7 are approved to treat UC in Japan. 8,9 The traditional primary treatment goal in UC has been the induction and maintenance of disease remission. However, the treatment goals for UC have evolved from resolution of UC symptoms to include objective measures such as mucosal healing.…”

“…The introduction of biologics has changed the treatment paradigm for moderately to severely active UC. Currently, adalimumab, infliximab, and golimumab, which target target tumor necrosis factor (TNF)-α, and vedolizumab, which blocks recruitment of immune cells to the gut by targeting α 4 β 7 integrin [ 7 ], are approved to treat UC in Japan [ 8 , 9 ].…”