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Unintended Consequences Of REMS Weighed On Entyvio Review Team

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA chose to focus on communication instead of use restrictions to manage PML risk with Takeda’s Entyvio after looking long and hard at REMS options and the potential unintended effects of the risk management plans on drug utilization.

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Legacy Cost: Takeda’s Entyvio Development Shaped By Tysabri Fallout

The specter of Tysabri and its restrictive REMS loomed over the review of Takeda’s Entyvio, making for an unusually high level of communication and discussion from Phase II until late in the review cycle – a tally that includes 14 pre-BLA face-to-face meetings between FDA and the sponsor, as well as two advisory committee reviews and two turns before FDA’s REMS Oversight Committee.

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