Takeda Avoids REMS For Entyvio, But Must Continue PML Monitoring
This article was originally published in PharmAsia News
FDA approves drug for ulcerative colitis and Crohn’s disease patients who have failed other therapies, but requires heightened adverse event reporting and post-marketing study.
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FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
The three new medicines tackle ulcerative colitis and Crohn’s disease, diabetes and ovarian cancer, respectively, with final approval from the European Commission expected in around two months.
Advisory committee decides overwhelmingly that PML risk has been adequately characterized, but still wants post-marketing observation. There was no clear decision on the extent of the program needed.