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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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