Takeda Avoids REMS For Entyvio, But Must Continue PML Monitoring
This article was originally published in PharmAsia News
Executive Summary
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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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.