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BioPharmaceutical Regulation Advisory Committees

Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow

This article was originally published in The Pink Sheet Daily

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Executive Summary

Merck rejected FDA's recommended endpoint to show efficacy in preventing C. difficile recurrence, which could make it difficult to gain approval for the product, headed to June 9 advisory panel review.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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